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Food and Drug Administration
Food and Drug Administration
Agency overview | |
Formed | June 30, 1906 (1906-06-30)[2] |
Preceding agencies |
Jurisdiction | Federal government of the United States |
Headquarters |
Employees | 14,824 (2010)[3] |
Annual budget | $5.1billion (2018)[4] |
Agency executives |
Parent agency | Department of Health and Human Services |
Child agencies |
Website | www.fda.gov [113] |
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[5] and veterinary products.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
The FDA has its headquarters in unincorporated White Oak, Maryland.[7] The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.[4] In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.[8]
Agency overview | |
Formed | June 30, 1906 (1906-06-30)[2] |
Preceding agencies |
Jurisdiction | Federal government of the United States |
Headquarters |
Employees | 14,824 (2010)[3] |
Annual budget | $5.1billion (2018)[4] |
Agency executives |
Parent agency | Department of Health and Human Services |
Child agencies |
Website | www.fda.gov [113] |
Organizational chart
Building 66 at the site of the former Naval Ordnance Laboratory
In recent years, the agency began undertaking a large-scale effort to consolidate its 25 operations in the Washington metropolitan area, moving from its main headquarters in Rockville and several fragmented office buildings to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, Maryland.[7][13] The site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak. The first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. Only one original building from the naval facility was kept. All other buildings are new construction.[14] The project is slated to be completed by 2021, assuming future Congressional funding[15]
Regional facilities
The Arkansas Laboratory in Jefferson, Arkansas is the headquarters of the National Center for Toxicological Research
Jamaica, Queens, NY Regional Office - USFDA
While most of the Centers are located in the Washington, D.C. area as part of the Headquarters divisions, two offices – the Office of Regulatory Affairs (ORA) and the Office of Criminal Investigations (OCI) – are primarily field offices with a workforce spread across the country.
The Office of Regulatory Affairs is considered the "eyes and ears" of the agency, conducting the vast majority of the FDA's work in the field. Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product.
The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. Districts are based roughly on the geographic divisions of the federal court system. Each district comprises a main district office and a number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.
The Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and don't focus on technical aspects of the regulated industries. OCI agents pursue and develop cases where individuals and companies have committed criminal actions, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving Title 18 violations (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI—and works with ORA Investigators to help develop the technical and science-based aspects of a case. OCI is a smaller branch, comprising about 200 agents nationwide.
The FDA frequently works with other federal agencies, including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work with the FDA to provide regulatory inspections and enforcement action.
Scope and funding
The FDA regulates more than US$2.4 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of these expenditures are for goods imported into the United States; the FDA is responsible for monitoring imports.[16]
The FDA's federal budget request for fiscal year (FY) 2012 totaled $4.36 billion,[4] while the proposed 2014 budget is $4.7 billion.[17] About $2 billion of this budget is generated by user fees. Pharmaceutical firms pay the majority of these fees,[17] which are used to expedite drug reviews.[18] The FDA's federal budget request for fiscal year (FY) 2008 (October 2007 through September 2008) totaled $2.1 billion, a $105.8 million increase from what it received for fiscal year 2007.[19]
In February 2008, the FDA announced that the Bush Administration's FY 2009 budget request for the agency was just under $2.4 billion: $1.77 billion in budget authority (federal funding) and $628 million in user fees. The requested budget authority was an increase of $50.7 million more than the FY 2008 funding – about a three percent increase. In June 2008, Congress gave the agency an emergency appropriation of $150 million for FY 2008 and another $150 million.[16]
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act,[20] (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies.
Regulatory programs
As of 2015, the agency regulates more than $1 trillion in consumer products, including:
$466 billion in food
$275 billion in drugs
$60 billion in cosmetics
$18 billion in vitamin supplements[21]
The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483.
In June 2018, the FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply".[22] One of the new guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable.
The FDA also uses tactics of regulatory shaming,[23] mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018, the agency published an online "black list," in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies.[24]
Canada-United States Regulatory Cooperation Council
On February 4, 2011, Prime Minister of Canada Stephen Harper and United States President Barack Obama issued a "Declaration on a Shared Vision for Perimeter Security and Economic Competitiveness"[25][26] and announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) "to increase regulatory transparency and coordination between the two countries".[27]
Health Canada and the U.S. Food and Drug Administration (FDA) under the RCC mandate, undertook the "first of its kind" initiative by selecting "as its first area of alignment common cold indications for certain over-the-counter antihistamine ingredients (GC 2013-01-10)."[28]
Food and dietary supplements
The regulation of food and dietary supplements by the Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
The FDA subdivides substances that it regulates as food into various categories—including foods, food additives, added substances (man-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. Specific standards the FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category.
"FDA-Approved" vs. "FDA-Accepted in Food Processing"
The FDA does not approve applied coatings used in the food processing industry.[29] There is no review process to approve the composition of nonstick coatings, nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not, and cannot be, considered as FDA Approved, rather, they are "FDA Compliant" or "FDA Acceptable".
FDA Building 51 houses the Center for Drug Evaluation and Research.
The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities: drugs that are not based on existing medications.
New medications
New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA).[30] Critics, however, argue that the FDA standards are not sufficiently rigorous, allowing unsafe or ineffective drugs to be approved.[31] New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed".
Some very rare limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols, as was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in a long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if a substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective.
Advertising and promotion
The FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission.
The drug advertising regulation[32] contains two broad requirements: (1) a company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug.
The term off-label refers to drug usage for indications other than those approved by the FDA.
Postmarket safety surveillance
After NDA approval, the sponsor must review and report to the FDA every patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis.[33] The FDA also receives directly adverse drug event reports through its MedWatch program.[34] These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary.
While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials, called Phase IV trials. In some cases, the FDA requires risk management plans ("Risk Evaluation and Mitigation Strategies" or "REMS") for some drugs that require actions to be taken to ensure that the drug is used safely.[35][36] For example, thalidomide can cause birth defects but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs.[35] There is also a REMS program called iPLEDGE for the drug, isotretinoin.[37]
Generic drugs
Generic drugs are chemical and therapeutical equivalents of name-brand drugs whose patents have expired.[38] Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration.In general, they are less expensive than their name brand counterparts, are manufactured and marketed by other companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States.[38] For approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug.[39] This is called an "ANDA" (Abbreviated New Drug Application). As of 2012, 80% of all FDA approved drugs are available in generic form.
Generic drug scandal
In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public.[38] Charges of corruption in generic drug approval first emerged in 1988, in the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from a complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within the federal agency resulted in racketeering and in violations of antitrust law. "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals)[40] pleaded guilty to giving bribes.
Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide, a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York.[38]
Over-the-counter drugs
Over-the-counter (OTC) drugs like aspirin are drugs and combinations that do not require a doctor's prescription.[41] The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision like ibuprofen.[42]
Ebola treatment
In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This is seen as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and continued as of August 2014.[43]
Vaccines, blood and tissue products, and biotechnology
FDA scientist prepares blood donation samples for testing
The Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents.[44] These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs.
The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.
Medical and radiation-emitting devices
The Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.[45] The definition of a medical device is given in the FD&C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators. CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.
CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.
"FDA-Cleared" vs "FDA-Approved"
Clearance requests are for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example it may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.[46]
Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear a warning to that effect.
According to the industry advocacy group the American Council on Science and Health, though the cosmetic industry is predominantly responsible in ensuring the safety of its products, the FDA also has the power to intervene when necessary to protect the public but in general does not require pre-market approval or testing. The ACSH says that companies are required to place a warning note on their products if they have not been tested and that experts in cosmetic ingredient reviews also play a role in monitoring safety through influence on the use of ingredients, but also lack legal authority. According to the ACSH, overall the organization has reviewed about 1,200 ingredients and has suggested that several hundred be restricted, but there is no standard or systemic method for reviewing chemicals for safety and a clear definition of what is meant by 'safety' so that all chemicals are tested on the same basis.[47]
Veterinary products
The Center for Veterinary Medicine (CVM) is a center of the FDA that regulates food additives and drugs that are given to animals.[48] CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by the United States Department of Agriculture.[49]
Tobacco products
Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has had the authority to regulate tobacco products.[50]
In 2009, Congress passed a law requiring color warnings on cigarette packages and on printed advertising, in addition to text warnings from the U.S. Surgeon General.[51]
The nine new graphic warning labels were announced by the FDA in June 2011 and were scheduled to be required to appear on packaging by September 2012. The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration.[52] R.J. Reynolds, Lorillard, Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company Inc. have filed suit in Washington, D.C. federal court claiming that the graphic labels are an unconstitutional way of forcing tobacco companies to engage in anti-smoking advocacy on the government's behalf.[53]
A First Amendment lawyer, Floyd Abrams, is representing the tobacco companies in the case, contending requiring graphic warning labels on a lawful product cannot withstand constitutional scrutiny.[54] The Association of National Advertisers and the American Advertising Federation have also filed a brief in the suit, arguing that the labels infringe on commercial free speech and could lead to further government intrusion if left unchallenged.[55] In November 2011, Federal judge Richard Leon of the U.S. District Court for the District of Columbia temporarily halted the new labels, likely delaying the requirement that tobacco companies display the labels. The U.S. Supreme Court ultimately could decide the matter.[56]
In July 2017, the FDA announced a plan that would reduce the current levels of nicotine permitted in tobacco cigarettes.[57]
Regulation of living organisms
With acceptance of premarket notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald Sherman permission to produce and market medical maggots for use in humans or other animals as a prescription medical device. Medical maggots represent the first living organism allowed by the Food and Drug Administration for production and marketing as a prescription medical device.
In June 2004, the FDA cleared Hirudo medicinalis (medicinal leeches) as the second living organism to be used as a medical device.
The FDA also requires milk to be pasteurized to remove bacteria.
International Cooperation
The FDA cooperated with international regulatory and law enforcement agencies through Interpol as part of Operation Pangea XI[58] from October 9 to October 16, 2018.[59] The FDA targeted 465 websites that illegally sold potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers. In terms of money laundering, the FDA targeted transaction laundering schemes in order to uncover the complex online drug network.[60]
Science and research programs
FDA lab at Building 64 in Silver Spring, Maryland
In addition to its regulatory functions, the FDA carries out research and development activities to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become impediments. The FDA's research efforts include the areas of biologics, medical devices, drugs, women's health, toxicology, food safety and applied nutrition, and veterinary medicine.[61]
Data management
The FDA has collected a large amount of data through decades. In March 2013, OpenFDA was created to enable easy access of the data for the public.
Harvey W. Wiley, chief advocate of the Food and Drug Act
Medical Officer Alexander Fleming, M. D., examines a portion of a 240-volume new drug application around the late 1980s. Applications grew considerably after the efficacy mandate under the 1962 Drug Amendments.
Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the short-lived Vaccine Act of 1813. The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry, later its Bureau of Chemistry. Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era.[62] The 1902 Biologics Control Act was put in place after a diphtheria antitoxin—derived from tetanus-contaminated serum—was used to produce a vaccine that caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named Jim, who had contracted tetanus.
In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act, also known as the "Wiley Act" after its chief advocate.[62] The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopeia or the National Formulary.[63]
The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.[62] Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent.[62] In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.[64]
By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.[65]
President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the 1951 Durham-Humphrey Amendment. These developments confirmed extensive powers for the FDA to enforce post-marketing recalls of ineffective drugs.[62]
In 1959, the thalidomide tragedy, in which thousands of European babies were born deformed after their mothers took that drug – marketed for treatment of nausea – during their pregnancies,[66] Considering the US was largely spared that tragedy because Dr. Frances Oldham Kelsey of the FDA refused to authorize the medication for market, the 1962 Kefauver-Harris Amendment to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority.[67] The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA approval process in its modern form.
These reforms had the effect of increasing the time, and the difficulty, required to bring a drug to market.[68] One of the most important statutes in establishing the modern American pharmaceutical market was the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the "Hatch-Waxman Act" after its chief sponsors. The act extended the patent exclusivity terms of new drugs, and tied those extensions, in part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the generic drug manufacturer need only demonstrate that their generic formulation has the same active ingredient, route of administration, dosage form, strength, and pharmacokinetic properties ("bioequivalence") as the corresponding brand-name drug. This act has been credited with in essence creating the modern generic drug industry.[69]
Concerns about the length of the drug approval process were brought to the fore early in the AIDS epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections.[70] Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life-threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options.[71] All of the initial drugs approved for the treatment of HIV/AIDS were approved through these accelerated approval mechanisms.[72] Frank Young, the commissioner of the FDA was behind the Action Plan Phase II, established in August 1987 for quicker approval of AIDS medication.[73]
In two instances, state governments have sought to legalize drugs that the FDA has not approved. Under the theory that federal law passed pursuant to Constitutional authority overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of these substances, even in states where they are legal under state law. The first wave was the legalization by 27 states of laetrile in the late 1970s. This drug was used as a treatment for cancer, but scientific studies both before and after this legislative trend found it to be ineffective.[74][75] The second wave concerned medical marijuana in the 1990s and 2000s. Though Virginia passed a law with limited effect in 1979, a more widespread trend began in California in 1996.
Historical first: FDA and Endo Pharmaceutical's Opana ER (2017)
When the FDA requested Endo Pharmaceuticals on June 8, 2017 to remove oxymorphone hydrochloride from the market, it was the first such request in FDA history.[76]
21st century reforms
Critical Path Initiative
The Critical Path Initiative[77] is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.[78]
Patients' rights to access unapproved drugs
The Compassionate Investigational New Drug program was created after Randall v. U.S. ruled in favor of Robert C. Randall in 1978, creating a program for medical marijuana.[79]
A 2006 court case, Abigail Alliance v. von Eschenbach, would have forced radical changes in FDA regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing.[80] The case won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The US Supreme Court declined to hear the case, and the final decision denied the existence of a right to unapproved medications.
Critics of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. The AIDS crisis created some political efforts to streamline the approval process. However, these limited reforms were targeted for AIDS drugs, not for the broader market. This has led to the call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.[81][82]
Post-marketing drug safety monitoring
The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999, and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004.[83]
Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials[84] for reforms in the FDA's procedures for pre- and post- market drug safety regulation.
In 2006, a congressionally requested committee was appointed by the Institute of Medicine to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.[85][86] Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill, which was signed into law in 2007.[87]
As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the postmarketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public.[88]
Pediatric drug testing
Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population. This became a major concern of pediatricians as evidence accumulated that the physiological response of children to many drugs differed significantly from those drugs' effects on adults. Children react different to the drugs because of many reason, including size, weight, etc. There were several reasons that not many medical trials were done with children. For many drugs, children represented such a small proportion of the potential market, that drug manufacturers did not see such testing as cost-effective.[89]
Also, because children were thought to be ethically restricted in their ability to give informed consent, there were increased governmental and institutional hurdles to approval of these clinical trials, as well as greater concerns about legal liability. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and body-surface-area calculations.[89]
An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs that had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However, this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications. However, this new rule was successfully preempted in federal court as exceeding the FDA's statutory authority.[89]
While this debate was unfolding, Congress used the 1997 Food and Drug Administration Modernization Act to pass incentives that gave pharmaceutical manufacturers a six-month patent term extension on new drugs submitted with pediatric trial data. The act reauthorizing these provisions, the 2002 Best Pharmaceuticals for Children Act, allowed the FDA to request NIH-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints. In the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.[89]
Priority review voucher (PRV)
The priority review voucher is a provision of the Food and Drug Administration Amendments Act (HR 3580) signed by President George W. Bush signed the bill in September 2007 which awards a transferable "priority review voucher" to any company that obtains approval for a treatment for a neglected tropical diseases. The system was first proposed by Duke University faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 Health Affairs paper: "Developing Drugs for Developing Countries".[90] In 2012, President Obama signed into law the FDA Safety and Innovation Act which includes Section 908 the "Rare Pediatric Disease Priority Review Voucher Incentive Program".[91]
Rules for generic biologics
Since the 1990s, many successful new drugs for the treatment of cancer, autoimmune diseases, and other conditions have been protein-based biotechnology drugs, regulated by the Center for Biologics Evaluation and Research. Many of these drugs are extremely expensive; for example, the anti-cancer drug Avastin costs $55,000 for a year of treatment, while the enzyme replacement therapy drug Cerezyme costs $200,000 per year, and must be taken by Gaucher's Disease patients for life.[92]
Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional drugs, and are produced through complex, often proprietary techniques, such as transgenic mammalian cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the Abbreviated New Drug Application (ANDA) process, in essence precluding the possibility of generic drug competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to create an ANDA process for the approval of generic biologics, but were not passed.[92]
Mobile medical applications
In 2013, a guidance was issued to regulate mobile medical applications and protect users from their unintended use. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps.[93] Incorporation of the guidelines during the development phase of such app has been proposed for expedite market entry and clearance.[94]
The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens.[62] As a result, the FDA's powers and decisions are carefully monitored by several governmental and non-governmental organizations. A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.[95][96]
Nine FDA scientists appealed to then president-elect Barack Obama over pressures from management, experienced during the George W. Bush presidency, to manipulate data, including in relation to the review process for medical devices. Characterized as "corrupted and distorted by current FDA managers, thereby placing the American people at risk," these concerns were also highlighted in the 2006 report[95] on the agency as well.[97]
The FDA has also been criticized from the opposite viewpoint, as being too tough on industry. According to an analysis published on the website of the libertarian Mercatus Center as well as published statements by economists, medical practitioners, and concerned consumers, many feel the FDA oversteps its regulatory powers and undermines small business and small farms in favor of large corporations. Three of the FDA restrictions under analysis are the permitting of new drugs and devices, the control of manufacturer speech, and the imposition of prescription requirements. The authors argue that in the increasingly complex and diverse food marketplace, the FDA is not equipped to adequately regulate or inspect food.[98] In addition, excessive regulation is blamed for the rising costs of health care and the creation of monopolies, as potential competitors are unable to get FDA approval to enter the market to compete and keep health care costs down.[99]
However, in an indicator that the FDA may be too lax in their approval process, in particular for medical devices, a 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovascular health purposes.[100]
See also
Drug Efficacy Study Implementation
Food and Drug Administration Modernization Act 1997
FDA Food Safety Modernization Act 2011
FDA Fast Track Development Program (for drugs)
Food and Drug Administration Amendments Act of 2007 (e.g. drugs)
Food and Drug Administration Safety and Innovation Act 2012 (GAIN/QIDP etc.)
Inverse benefit law
Investigational Device Exemption (for use in clinical trials)
Kefauver Harris Amendment 1962 – required "proof-of-efficacy" for drugs
Adverse reaction
Adverse event
Adverse drug reaction
Food Administration
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Brazil: National Health Surveillance Agency
Canada: Marketed Health Products Directorate
Canada: Health Canada
Denmark: Danish Medicines Agency
European Union: European Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Food Safety and Standards Authority of India
India: Central Drugs Standard Control Organization
Japan: Ministry of Health, Labour and Welfare (MHLW)
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for the Protection against Sanitary Risk
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration


text:
Export 12 results:
Filters: Author is Jenkins, Michael A [Clear All Filters]
Spatial Patterning and Population Structure of a Common Woodland Herb, Trillium erectum, in Primary and Post-Logging Secondary Forests." Forest Ecology and Management 258, no. 11 (2009): 2569-2577.
"Soils Inventory Unearths New Species at Great Smoky Mountains National Park." In Natural Resource Year in Review - 2002: A Portrait of the Year in Natural Resource Stewardship and Science in the National Park System, edited by Natural Resource Information Division, 25. Washington, D.C.: National Park Service, 2003.
"Effects of Chronic Herbivory and Historic Land Use on Population Structure of a Forest Perennial, Trillium catesbaei." Applied Vegetation Science 10, no. 3 (2007): 441-450.
"Impacts of an Exotic Disease and Vegetation Change on Foliar Calcium Cycling in Appalachian Forests." Ecological Applications 17, no. 3 (2007): 869-881.
"Cornus florida L. Mortality and Understory Composition Changes in Western Great Smoky Mountains National Park." Journal of the Torrey Botanical Society 129, no. 3 (2002): 194-206.
"Yellow pine regeneration as a function of fire severity and post-burn stand structure in the southern Appalachian Mountains." Forest Ecology and Management 262 (2011): 681-691.
"Impact of the Balsam Woolly Adelgid (Adelges piceae Ratz.) on an Abies fraseri (Pursh) Poir. Dominated Stand near the Summit of Mount LeConte, Tennessee." Castanea 68, no. 2 (2003): 109-118.
"Vegetation Communities of Great Smoky Mountains National Park." Southeastern Naturalist 6, no. sp2 (2007): 35-56.
"Thematic Accuracy Assessment: Great Smoky Mountains National Park Vegetation Map. Great Smoky Mountains National Park, Gatlinburg, TN: National Park Service, 2007.
Vegetation and Ecology of the ATBI Plots." ATBI Quarterly 2, no. 3 (2001): 6-7.
"Effects of Chronic Herbivory and Historic Land Use on Population Structure of a Forest Perennial, Trillium catesbaei." Applied Vegetation Science 10, no. 3 (2007): 441-450.
"Exotic Plant Species Invasion and Control in Great Smoky Mountains National Park, USA." In Invasive Plant and Forest Ecosystems, 295-322. New York: CRC Press, 2009.

subset: commoncrawl


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Cygwin is a wonderful tool. However, I don't really like the default terminal. This article shows how to set up an rxvt terminal instead.
This is a screenshot of the default cygwin bash prompt:
Copying and pasting is not intuitive, you can't stretch the box horizontally, and most importantly, it breaks the illusion that I'm on a Unix box. But a better terminal option exists! When you install cygwin, you can also install the rxvt package. After installing the rxvt package, try this in a DOS window:
C:\cygwin\bin\rxvt.exe -fg gray -bg MidnightBlue -fn "Lucida Console-14" -e bash --login -i
You should see a terminal like this:
As far as I can tell from my experience, this terminal acts exactly like a regular rxvt terminal on a linux box. I can highlight some text with my mouse, and then paste it by hitting either shift+insert or by hitting the middle mouse button. I can resize the terminal horizontally and vertically.
I set up a taskbar icon so that I can get that rxvt very quickly. The icon before the right-most icon will start an rxvt terminal for me.
Setting it up was really simple. I made a new shortcut by right-clicking on my desktop, then I copied this text:
C:\cygwin\bin\rxvt.exe -fg gray -bg MidnightBlue -fn "Lucida Console-14" -e bash --login -i
into the target field:
Then I hit OK, and then dragged the new shortcut into the taskbar, and that's it!


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It's come to our attention that some truly bizarre looking creatures are being served up in seafood restaurants in Shizuoka lately. Ever since a new deep sea aquarium opened up in Numazu just over a year ago, deep sea seafood has been all the rage in the area. Monkfish, scorpionfish, lumpsucker and rosy seabass are being served up as sushi, sashimi or simply on a bed of rice, in local restaurants.
Pioneering this local trend has been Uoshige Shokudou, a restaurant that serves up a weird and wonderful deep sea sashimi platter that varies according to the season. The most expensive item on the menu, costing between ¥10,000 to ¥15,000 ($101 to $151), is the Japanese spider crab that lives at depths of 600 meters.


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Latinos Run Printed Shirt
Printed Design
Crew Neck, Short Sleeves
Made with super lightweight fabric
Rapidly transfer moisture away from the body and increase vaporization
Maximum cooling for your body
Anti-odor technology prevents the growth of odor-causing microbes
Proven and tested for elite performance.Material and Cares
100% Polyester
Machine wash cold
Remove promptly
With like colors
Do not bleach
Tumble dry low
Do not iron
Do not use fabric softener
Latinos Run Ladies Printed Shirt
Shipping: Latinos Run Ships Monday-Friday.
Orders take 7-10 business days to arrive.
For express orders, please email us directy at email@example.com
For International orders, please email us directly at firstname.lastname@example.com
Return and Exchange Policy
- No returns will be accepted without prior written authorization - Merchandise can only be exchanged within 10 days of receipt for store credit only. No refunds.
- Return/Exchanged items must be in unused and unopened condition with origional tags/packing slip attached.
- Authorized merchandise returned/exchanged after the 10 day policy will be charged a 20% restocking fee.
- Items that do not meet above criteria or are non-returnable/exchangeable will be denied.
Process: For all Returns, Exchanges, and Damages, please email us at email@example.com and call us at 954-336-5972 to receive a Return Authorization number. We will email you a Return Authorization form to ship back along with your Returned Authorization number and Unused merchandise. Please include the RA form with the items you are returning in the order you are shipping back. For exchanges on undamaged goods, buyer will be responsible for any new shipping and handling charges.
Returns for Store Credit: Once we receive your package, we will issue Store Credit to your customer account within our internal system. You will receive a confirmation email regarding details to your Store Credit Once we receive your returned merchandise. Store credit will not be credited to your account until we receive the returned merchandise.
Exchanges: Once we receive your returned merchandise, we will credit the amount returned to the new merchandise you are exchanging for. If there is store credit left over, we will email you to inform you of your remaining balance. If the credit does not cover the cost of the entire order, we will inform you of the remaining order amount balance.
Virtual Runs: All Virtual Run items and Sale items are Final Sale. No Refunds or Exchanges will be made. Latinos Run is not responsible for any cancellations, delays, or interruptions of in-person events due to weather or natural disasters. For questions, please contact us directly at email@example.com
In-person pickup: Item must be retrieved by day of event. Failure to pickup may result in forfeit of items. If unable to attend event, please contact Latinos Run directly to arrange alternative pickup. Items not picked up within 2 weeks will be forfeited. If you requested pickup for out of state event, and you were unable to pickup your items, buyer is responsible for shipment of goods. All Virtual Runs items are final sale. No refunds or exchanges.
Discount: In the event of a Promotion, all discounts must be entered at time of sale. No discounts will be applied after. For any issues entering discount codes, please email firstname.lastname@example.com with subject line "Discount"
****Please note Discount cannot be used in exchange for previously sold items. Only 1 discount per transaction. Cannot be combined with any other offer, promotion, or group.Cancellation Policy: To cancel orders placed with us at Latinos Run, please contact us by phone (954)336-5972 or by sending an email at firstname.lastname@example.com. Cancellation requests must be made within 24 hours from the time the order was placed. Cancellations require authorization before order completion and we reserve the right to charge up to 15% of the value of the canceled merchandise for handling. Confirmed cancellations will be reflected in the "Order Status" as "Canceled" after they have been approved.
Do you sell Wholesale?
YES! We are a Store and a Wholesaler. Many of our product lines we carry sell to Individuals and Teams. We also offers custom production to the public. So hit us us about your needs.
Serious inquiries only please. Email: email@example.com Items: In the event of a Presale, items will list expected shipping date. To pre-order and item, your credit card will be charged at the time the order is placed. We will ship the item(s) to you on the actual availability date. Therefore, your total time for delivery would be: Total Time for Delivery = Time Until Availability Date + Delivery Time Frame (based on the shipping method chosen during the checkout process).
Availability dates are supplied by the manufacturer or distributor of the product and are subject to change without notice. Once we learn about any changes to the availability date, we update the availability information on our site. For questions, please email LatinosRun.com with subject line "Preorder"


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Justin Bieber Under Fire After Saying He and Kendall Jenner 'Can't Feel Bad for the Things We Have' During the Pandemic
Justin Bieber is facing backlash after he shared a comment about being extremely fortunate during the coronavirus (COVID-19) pandemic.
The 26-year-old held an Instagram Live session on April 5 where he chatted alongside his wife, Hailey Bieber, with a number of celebrity guests including Kendall Jenner.
While speaking with the model, Bieber brought up the subject of the state of the world and privilege. "How blessed are we to be able to like… a lot of people obviously in this time have a crappy situation," he said. "You know, they look at us and obviously, we've worked hard for where we're at, so it's like, you can't feel bad for the things we have."
"But I think, just us taking that time to acknowledge that there are people who are really crippling is important," he added before Jenner agreed saying how blessed they are.
Social media users spoke negatively about his insensitive comments. Users felt that he was bragging about his privilege and some even asked him to donate instead of just acknowledging the less fortunate.
See the video, below.
See fan reactions, below.
22 Things You Didn't Know About Justin Bieber


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Job hunting is like dating
Paul Buchheit posted an interesting analysis of social networking products, their similarities and differences. In there he has hidden a rare gem:
10. Jobs. Job hunting and hiring are essentially the "professional" analog of dating and seem to work in somewhat similar ways.Shaking Hands, by Aidan Jones
If you ponder it a bit, it sounds about right, doesn't it? People look for jobs they like and hiring managers look for candidates they like. When there is a match, there is a hire. The parallels are many:
- Dumping/seduction: an employee will dump his current job for a better one, often due to seducing promises from their hiring manager.
- Bachelorhood/marriage: some people change jobs like crazy (especially in the States), while others stick to one for life (quite common in Japan).
- Stagnation: employment relationships, like sexual ones, tend to stagnate after a long period of time, when people lose interest in it.
- We might as well admit it, women and work are the two dominant discussion subjects with one's friends, after midnight.
- When one gets caught cheating on his wife/company, they go to court.
- Girls have breasts, jobs have salaries. The bigger, the better.
- People get jealous of their friends who make more money than they do.


text: The VARTA Power Banks are your most competent energy companions you can rely on in any situation. Advanced safety features combined with the latest tech trends to keep you and your mobile devices safe. Whether it is a smartphone, tablet or a smartwatch, the VARTA Power Banks keep your devices powered and you will never run out of energy again.


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If you are new to my blog, welcome!!! The CoffeeShop Blog is a one-woman-owned business (by me, Rita!) and I create all of the tutorials and freebies posted here. If you want to grab hundreds of my Photoshop/PSE actions (including exclusive sets not found here on my blog), Lightroom Presets, and professional digital designs (including all of my favorite holiday sets) in a single download AND help support my site please check out my CoffeeShop Download Pack. Thanks to you The CoffeeShop Blog is possible.
You must understand how to use layer masks to use this action, so please go read my Layer Mask tutorial and if you have PSE8 or below you might want to download my free layer mask action. You don't need to add your own layer masks to use this action (they are built in), but once you start using layer masks you won't want to stop.
Remember, this is the way I usually edit using this action, but you might find a way that you think works better!
1. Open your image and run CoffeeShop Eye Bright. You will have four layers but your image will be unchanged. I have so many people email me and ask why there is no change on their image after they run this action. This action needs user input to get stunning and realistic results.
The Eye Define layer mask is already selected. Black masks "mask" any change.
2. Zoom in the eyes.
3. Click "B" to select your brush, then "D" for default black foreground and white background, and then "X" to make your foreground color white. Your brush has to be white to edit all of these layers! Make your brush soft, make sure it is in normal mode, and put the opacity at 100% for this step.
4. I like to make it easy to see where I am editing, so I click Alt-Shift while clicking on my black layer mask in the Eye Define layer. Now my entire image is red, which allows me to see where I am painting in the image. You can also click on the backslash \ key to get the same effect.
5. Now I take my brush which I adjusted in Step 3 and paint over the iris in each eye. Wherever I paint on the image I remove the red, which means I am defining that part of the eye. If you go over the whites, just click "X" to make your brush black and repaint over the part you want to remove.
6. Then I usually bring the opacity down to 50% or so and paint over the eyelashes and eyebrows. Make sure you don't paint on the edges of the bottom of the eye just above the bottom eye lashes. This can make the eyes look really odd. And remember, as long as you are holding your mouse down when you paint, the opacity will continue to be 50% even if you repaint over an area.
7. Shift-Alt to remove the red mask and then click on the White Whites' black layer mask. Click Shift-Alt to turn on the red mask again. Then make sure your brush is white and set to around 50% and paint over the whites of the eye. Be careful to not paint on the black part of the iris or the skin around the eye. You can see below I painted over the bottom part of the iris, so I changed to a black brush and painted the iris out.
Shift-Alt to remove the red mask when you are done.
8. Click on the Bright Eyes layer. Use a white brush at 100% opacity to paint over the color parts of the eye. Make sure to avoid any areas that are black.
9. Now, this is probably the most important part of the eye editing process. We have all seen retouching gone wild in photography, where children or adults look like plastic space aliens... So be sure to zoom out and examine your eyes and make sure they look normal. In this case, I think we need to do some final adjustments.
10. I usually don't do anything to the Eye Define layer, but I always bring down the opacity of the Bright Eyes and White Whites layers. You can see my final setting below.
11. I still think the eyes are a bit overdone, but I could go back and play with the settings again. This simple little action can really enhance the eyes in your portraits.
If you want to do a complete retouching job with these Eye Bright and auto skin smoothing, etc., please go download my free CoffeeShop Perfect Portrait 3 action. I have so many other retouching actions, and you can find them all on this page (go down a bit) or download my most popular ones in one simple download and help support this blog here.
I also have a new action coming out that has Eye Bright and the auto skin smoothing from Perfect Portrait 3. Once I figure out a name I will post it here. I posted a sample before/after below, and that edit took maybe 2 minutes. This action is perfect to use on an already edited portrait that just needs some simple retouching.
Do you want to download my favorite CoffeeShop Actions or Design Elements in one convenient zipped file AND help support this blog? Just click here for my action pack or here for a download of some of my most popular design elements, storyboards, and textures.
For complete info on installing all of my actions, click here.


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Personal skills are defined by reference to the effects on the individual's capacity (mental, social etc.). This detailed field covers personal skills programmes not included in 0011 'Basic programmes and qualifications' or 0021 'Literacy and numeracy', giving key competencies and transferable skills.
Programmes and qualifications with the following main content are classified here:
Argumentation and presentation
Assertiveness training
Communication skills
Development of behavioural capacities
Development of mental skills
Job-seeking programmes
Parenting courses
Public speaking
Self-esteem skills
Social competence
Time management
Education and training in leadership in the context of personal development is included here.
Education and training related to the work place or to work assignments is included in this detailed field if it has more to do with personal development than work development. Personal skills courses can be taught at the workplace, but still be classified here based on their content.
Programmes for people with special needs on how to cope with their daily life are included here
Study of leadership in the context of management is excluded from this group and included in detailed field 0413 'Management and administration'.


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The national Tribal Pollution Prevention Network (Tribal P2) is proud to announce the launch of the newly renovated TribalP2.org website. The website provides resources, current funding opportunities and events, and collaborative connection assistance in 19 different topic areas – from Solid Waste to Green Casinos to Climate Change.
One goal of the Network is to facilitate collaboration among peers, mentors, and experts in topics related to pollution prevention. To that end, the new website features an interactive member map that provides contact information for Network members across the nation. Many of the Network's members have agreed to be collaborators – which means they are willing to share their expertise with you.
Visit the site to learn about pollution prevention (P2) opportunities and identify peers with expertise to share. Join the Network listserv to receive information on regularly scheduled webinars, news, announcements and funding opportunities pertaining to timely and relevant P2 topics.
"…it all looks great! I really like the way you set up the website […] it should be very beneficial for all the Tribes needing help on difficult issues." Donna Marie Noel, Energy Project Manager Water Resources Department, Pyramid Lake Paiute Tribe
"…the listings are formatted in a user friendly way for communication and searching. It is a great tool!" Stan Belone, Environmental Engineer Air Quality Program, Environmental Protection & Natural Resources, Salt River Pima-Maricopa Indian Community
The Tribal P2 Network was formed in December 2003 from an EPA grant issued as a result of tribal requests for more specific tribal communication about Pollution Prevention (P2) efforts directly relating to tribes. Tribal P2 consists of environmental professionals from tribal entities, local, state and federal agencies, academia, and not-for-profit organizations around the nation. The major objective of Tribal P2 is to share information and identify solutions to address environmental issues affecting the tribal nations using pollution prevention methodologies. Membership in the Network now stands at over 250 individual participants, with over 90 Tribes participating.


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What happened to hybrid MDM?
Applies to: Configuration Manager (current branch)
Microsoft retired the hybrid MDM service offering as of September 1, 2019. Any remaining hybrid MDM devices won't receive policy, apps, or security updates.
Remove hybrid MDM
If your Configuration Manager site had a Microsoft Intune Subscription, you need to remove it.
In the Configuration Manager console, go to the Administration workspace. Expand Cloud Services, and select the Microsoft Intune Subscription node. Delete your existing Intune Subscription.
In the Remove Microsoft Intune Subscription Wizard, select the option to Remove Microsoft Intune Subscription from Configuration Manager, and then click Next.
Complete the wizard.
Deprecation announcement
The following note is the original deprecation announcement:
As of August 14, 2018, hybrid mobile device management is a deprecated feature. Starting with the 1902 Intune service release, expected at the end of February 2019, new customers can't create a new hybrid connection.
Since launching on Azure over a year ago, Intune has added hundreds of new customer-requested and market-leading service capabilities. It now offers far more capabilities than those offered through hybrid mobile device management (MDM). Intune on Azure provides a more integrated, streamlined administrative experience for your enterprise mobility needs.
As a result, most customers choose Intune on Azure over hybrid MDM. The number of customers using hybrid MDM continues to decrease as more customers move to the cloud. Therefore, on September 1, 2019, Microsoft will retire the hybrid MDM service offering.
This change doesn't affect on-premises Configuration Manager or co-management for Windows 10 devices. If you're unsure whether you're using hybrid MDM, go to the Administration workspace of the Configuration Manager console, expand Cloud Services, and select Microsoft Intune Subscriptions. If you have a Microsoft Intune subscription set up, your tenant is configured for hybrid MDM.
How does this affect me?
Microsoft will support your hybrid MDM usage for the next year. The feature will continue to receive major bug fixes. Microsoft will support existing functionality on new OS versions, such as enrollment on iOS 12. There will be no new features for hybrid MDM.
If you migrate to Intune on Azure before the end of the hybrid MDM offering, there should be no end user impact.
On September 1, 2019, any remaining hybrid MDM devices will no longer receive policy, apps, or security updates.
Licensing remains the same. Intune on Azure licenses are included with hybrid MDM.
The on-premises MDM feature in Configuration Manager isn't deprecated. Starting in Configuration Manager version 1810, you can use on-premises MDM without an Intune connection. For more information, see An Intune connection is no longer required for new on-premises MDM deployments.
The on-premises conditional access feature of Configuration Manager is also deprecated with hybrid MDM. If you use conditional access on devices managed with the Configuration Manager client, make sure they are protected before you migrate.
- Set up conditional access policies in Azure
- Set up compliance policies in Intune portal
- Finish hybrid migration, and set the MDM authority to Intune
- Enable co-management
- Move the compliance policies co-management workload to Intune
For more information, see Conditional access with co-management.
What do I need to do to prepare for this change?
Start planning your migration for MDM from the ConfigMgr console to Azure. Many customers, including Microsoft IT, have gone through this process. For more information, see this Microsoft case study.
Contact your partner of record or FastTrack for assistance. FastTrack for Microsoft 365 can assist in your migration from hybrid MDM to Intune on Azure.
For more information, see the Intune support blog post.
Next steps
For more information on supported features for managing MDM devices, see the following articles:
Coming soon: Throughout 2024 we will be phasing out GitHub Issues as the feedback mechanism for content and replacing it with a new feedback system. For more information see:Submit and view feedback for


text:
Dental Insurance is equally important to Health Insurance because dental disease is still very prevalent.
Dental care is a very important part of any healthy lifestyle, but because dental insurance or dental coverage is not included as part of standard health care insurance, it is something that is often overlooked or forgotten until it is too late. The rising cost of quality dental care means that dental insurance might be just what you and/or your family need to ensure that your teeth remain health and well cared for.
Dental Insurance works very much like health insurance - they come in a variety of "flavors" if you will. PPO, DHMO, POS, Indemnity and Scheduled.
PPO PPO stands for Preferred Provider Organization. Basically, the network of dentists that the members are referred to offer discounted fees to the plan members.You can typically use a dentist outside of the PPO's network, but you will only be reimbursed the discounted fee for the services rendered and have to pay any additional amount yourself.
DHMO DHMO stands for Dental Health Maintenance Organization. The way a DHMO works is it provides you dental services through its network of dentists in exchange for some form of prepayment. If you use a dentist outside of the network, you will most likely be responsible for the entire bill.
POS POS stands for Point of Service. A POS plan allows you to use either a DHMO dentist or a dentist not in the network. You get to choose in-network care of out-of-network care when you make your dental appointment and typically, you will incur higher out-of-pocket costs for out-of-network care.
Indemnity. An indemnity plan is also known as a traditional plan. With an indemnity plan you can visit any dentist you like. They typically pay a percentage of "usual, customary and reasonable" charges for covered services.
Scheduled. A scheduled plan or scheduled reimbursement plan reimburses you for a set amount based on a fee schedule. The balance due, if any is your responsibility. They include a calendar year maximum, a deductible and waiting periods for certain procedures.
Most dental coverage is designed to ensure that the patient receives regular preventive care.
There are three (3) categories of dental procedures.
When you're shopping for a dental plan there are a number of things you'll need to keep in mind, to make sure that you end up with a policy that's right for you and your situation. As each individual and family have different circumstances please contact us today to evaluate your dental insurance needs and we will work to find the plan the best fits your needs and budget.
©All Insurance Agency, Inc., 2012 Powered By: Insurance Web Designs webmail login


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The Role of Technology in Our Society
- by siteadmin
Technology is the application of scientific knowledge to practical goals in human life. Its applications are diverse and are used in a variety of fields. These days, you can't imagine a human being living without using some type of technology. Technologies are used in various ways, from automobiles to computers to cell phones.
Application of Scientific Knowledge to the Practical Aims of Human Life
Technology is a set of techniques, skills, and processes used to produce and transform matter. Its applications range from creating tools for construction to enhancing the quality of life. Technology is the application of scientific knowledge for the benefit of humankind. It is not limited to electronic equipment and instruments but can also include inventions and new communication methods.
In the beginning, technology developed out of the personal experience and the methods that were used to manipulate things. Many of these techniques were passed on from one generation to another. Today, most technologies, tools, and medicines are scientific research products. Although these are often the products of a single practitioner's work, the development process is rooted in a deeper understanding of scientific principles.
Technology has shaped human society for thousands of years. There are three distinct types of human technology: prehistoric, Neolithic, and Lithic. In human history, technological change has played a fundamental role in nearly every significant historical development. In addition to the practical aims, the impact of technology is often driven by societal decision-making.
Technology also includes engineering, which is the systematic application of scientific knowledge. With this approach, scientists can predict and estimate the behavior of things before they are made. It also allows scientists to design new technologies that solve real-world problems. In addition to meeting human needs, engineers can also predict human behavior.
As science has shaped human society, technology has also changed the way that people live their lives. It has helped humans control their environment. The use of technology can make human life easier and work more productive. People have begun using tools to aid in their daily tasks. With the Industrial Revolution, technology took on a more rapid pace as machines replaced both animal and human labour. However, this rapid development has not been without its drawbacks, including air pollution and other undesirable environmental effects.
While it is rare for individual citizens to question the application of technology on a larger scale, their decisions can significantly impact the use of technology in human life. The decision-making process for new technologies is often influenced by political factors as much as by technological factors. Nevertheless, scientists are able to look ahead as far as possible to predict the risks, benefits, and side effects of new technologies. They can also design monitoring systems and set up procedures to collect relevant data.
It is Not Neutral
The role of technology in our society is not always neutral. Some forms of technology, such as the internet, affect us in ways we might not expect. These types of technologies can have an impact on power arrangements in society and enterprises. We should consider these impacts when determining if a technology has a neutral or non-neutral role.
Hare starts by exploring the concept of technology's neutrality and distinguishes its impact and intention. She then discusses animal intelligence, drawing a contrast between chimpanzees using spears to hunt and hermit crabs borrowing the shells of other animals. She argues that the former is an example of intelligent use of technology, while the latter may simply result from genetic coding.
The use of computers in the military is one example of technology that is not neutral. This kind of technology can be extremely powerful, especially in the hands of the military. This type of technology can be used for good or evil, but in the wrong hands, it can be abused to cause wars and other negative consequences. In addition, there are ill effects of excessive computer use. Many people suffer from computer-related health issues.
Technology Is Not Neutral is a short guide to technology ethics, written for all those who are involved in creating, using, investing in, or regulating technology. It will help you become more knowledgeable about these issues and empower you to hold technology accountable for its actions. It will help you think about what your actions mean for others and the world.
Television is another example of a technology with non-neutral properties. It is non-neutral because of the way that it broadcasts content. While wealthy people can use it to promote their products and services, the poor will not. If enough people use it, patterns of use will emerge. These effects can harm our children and society, so we must be aware of this and act accordingly.
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Technology is the application of scientific knowledge to practical goals in human life. Its applications are diverse and are used in a variety of fields. These days, you can't imagine a human being living without using some type of technology. Technologies are used in various ways, from automobiles to computers to cell phones. Application of…
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Baby Knit #40 ~ Handmade by Oms' Knit
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text: This is an integrable system: denoting $y=x'$ we get\begin{equation*}H(x,y) := \frac{1}{2}y^2 \underbrace{-\frac{1}{5}x^5+\frac{5}{3}x^3 -4x}_{V(x)}=E\end{equation*}wehre $V(x)=-\int f(x)\,dx$, $f(x)=x^4-5x^2+4$ is the r.h.e. $V(x)$ is a potential.Since $V(x)$ has non-degenerate maxima at $x=-1$ and $x=2$ and minima at $x=-2$ and $x=1$ and $\frac{1}{2}y^2$ has non-degenerate minimum at $y=0$ we have 4 non-degenerate critical points of $H(x,y)$: namely, $(-1,0)$ and $(2,0)$ are saddle points and $(-2,0)$ and $(1,0)$ are minima.For dynamics two former are saddle points and two latter re centers (recall that integrable systems cannot have spiral or nodal points and centers are detectable!)What is missing for everyone? Plot of $V(x)$ which shows that $ V(-1)>V(-2)>V(2)>V(1)$ (one needs just calculates them) and therefore picture must be like on Jason' computer generated and not Yeong' drawing since separatrix passing through saddle $(-1,0)$ is "higher" and therefore envelops saddle $(2,0)$ and cannot pass through it as Yeong drew. And therefore separatrix passing through $(2,0)$ stops short and goes back to the right from $(-1,0)$ (not passing through it). If in some examples we studied before separatrices passing through different saddles are the same it is not the general rule.To analyze Jason's picture:a) Look at the centers b) Find separatrix passing through $(2,0)$c) Find separatrix passing through $(-1,0)$


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Rise Against Announce 'Wolves' Album, Release New Track 'The Violence'
Rise Against are back with another a punk-rock anthem, "The Violence." The cut is Rise Against's first song released from their upcoming eighth studio album, Wolves.
People around the world are wondering about the state of punk rock in the Trump era. Will it gain massive amounts of support and traction like it did in the Bush years? We'll see how it all unfolds with Rise Against being one of the first prominent punk acts to release new material in 2017.
Rise Against sound just like themselves with "The Violence," as frontman Tim McIlrath ramps up his distinctive vocal style over buzzing guitars and marching drum beats. The entirety of Wolves was recorded in Nashville, Tenn., which affected the outcome of their new record.
"Living in Nashville drove home that we can't just focus on our differences," says McIlrath. "If we can stop and talk to each other, face to face, we might realize our common ground. We are all wolves in the same pack, circling at the gates."
Along with a June 9 album release via Virgin Records, Rise Against have also announced a pair of House of Vans shows. The band will rock Chicago on April 21 and Brooklyn on April 24 before heading out on tour with Deftones and Thrice this summer.
Check out "The Violence" above and be sure to pre-order Wolves by clicking here.
Most Anticipated Upcoming Hard Rock + Metal Albums of 2017


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VLC is beyond doubts the most popular open source, cross-platform media player and multi-media framework written by VideoLAN projects. VLC player is small in size, just about 17 Mb and immensely powerful! In this post we will explore the player and list 25+ things you can do with VLC player.
1- Run/Install VLC from flash drives
VLC can be installed or run directly from a flash or other external drive. It is light weight and small in size.
2- Portability: Play any DVD on the go, ignoring region coding
For the new bees, I will throw some light on DVD regions. According to Wikipedia there are six different official regions and two informal variations. Any DVD discs may use one code, a combination of codes (Multi-Region), most codes (Region 0) or every code/no codes (Region All). Any commercial DVD player specification requires that a player to be sold in a given place not plays discs encoded for a different region. Put it simply;
DVDs manufactured for one region will not play in players made for a different region. Usually to play dvds from other region you often require illegal DVD region spoofing programs. However VLC player is so powerful that it can play DVD's encoded for any region .i.e. it ignores region coding. This feature is so helpful if you are an international traveler and require playing DVD outside the country.
3- Play anything, audio or video!
VLC player can play any common audio formats (OGG, MP3, WAV ,WMA….) and almost all kinds of video file formats, including rare file formats, without installing external codecs. VLC player is an ideal replacement for even ITunes . That is to say you would never get the annoying notifications saying it "your player needs a codec for MP4, FLAC or Raw DV…"! play anything you want!
4- AirTune Streaming
AirTunes is functionality for Apple's Airport Express. This functionalities allows one to play media files on your home stereo speakers. This feature was initially developed to work with iTunes, but now VLC has officially added the support for AirTunes streaming as well.
5- Effortlessly use VLC player with other programs
Its my personal experience that powerful players that offer flexibility are very heavy on system resources. You can only play the player and your multi-tasking is literally paralyzed. That is just not the case with VLC. Whether you are playing ti on Mac, Windows or Linux, you will feel VLC is light and enables you to extensively multitask.
6- Minimize VLC player to system try!
7- Convert your files using VLC
VLC is amazing!! You can convert your media files using VLC player. VLC can also convert videos to formats it supports and one can also specify whether or not to use system codecs. I have loaded an mp3 file that I can convert to acc, mp4, OGG,ASF TF etc!
Another interesting consequence:
Usually pdf files cannot be read with multimedia files in mobiles. You can convert your pdf files to to MP3 or MP4. This way they can be read on any multimedia plaer and also will consume much less space. To convert simply Menubar->Media->Convert/Save.
8- Screenshot your video!
With VLC one can also take screenshots of videos, even during DVD playback. This is indeed a very attractive feature. To capture a snapshot go to Menubar->Video->Snapshot
9- Play subtitles
When playing a movie you might not always have the option of playing subtitles. In such a case you can download subtitles from website like moviesubtitles.org. You can either rename the subtitle file to match the name of your movie or you can browser the file to enable it. In the previous case (renaming the file) play the file and simply right-click on the screen and go to subtitles, you will be surprised! The subtitles are already enabled! In the later case, you can manually browse the subtitles file and enable it by File->File Open->Check the Use Subtitles checkbox ->browse the file->play.
10- Add Logo to your video like a TV!
You can add logos to your video by following the following simple steps:
- First install vlc-nox and mono-devel:
sudo apt-get install vlc-nox mono-devel
- Go to the folder where you have your video + logo.png (make sure to place the logo and the video int he same directory)
- In local type the following command : vlc –sub-filter logo –logo-file logo.png video.avi
- In streaming: vlc –logo-file logo.png video.avi –sout "#transcode{vcodec=…,vb=…,sfilter=logo}:std{…}"
- Note: Do not specify –sub-filter logo, and that you specify a vcodec= value in the transcode part
- Save the video locally with the logo:
vlc --logo-file logo.png video.avi --sout "#transcode{vcodec=...,vb=...,sfilter=logo}:std{access=file,dst=new_video.avi }
11- Control and customize VLC
One can easily control the VLC player with keyboard/joy sick using Hotkeys and perform various fucntions like switch to full-screen, begin playback, pause playing, speedup or slow playback or skip to next section. bbb You can refer to the list of hotkeys here. The most exciting things is that you can completely customize the hotlkeys to suit your use. In later post we will let you know how you can customize the hotkeys.
12- View fullscreen videos and simultaneously control the player with hotkeys. Hotkey: Ctrl+H
13- View videos with minimal interface. i.e watch vidoes in fullscreennd keep watch on other applications in the taskbar as well. Hotkey: F11
14- Customize interface of VLC
VLC player gives the user the freedom to customize its interface. You may want to make the player look more colorful and fancy as by default the interface is fairly plain. You can accomplish it in 2 ways:
- Either customize the VLC player qt interface.
- Install skins
In the upcoming post we have introduced you to VLC players interface in detail.
The above figure is interface of VLC that is skinned.
15- Control VLC remotely!
You can control VLC player remotely from a computer that does not even have VLC. all you need to do it to enable access in the .hosts file (from 0.9.6 onwards) and follow as below:
- Add the files to be streamed to the playlist like /home/file.mpg (unless you use the UI to select the file in the next step)
- Add streaming destination to the server in the sout field udp://:1234, using these steps in the UI:
- Go to File -> Open File
- Click Browse to select the file you want to play
- Select Stream/Save and click Settings
- Optional: Select Play Locally to make sure everything is working correctly
- Select UDP and fill in the client IP address and port number (default: 1234)
- Click OK, OK, and press play
- At the terminal, with vlc udp://@:1234
- Start up VLC normally Go to File -> Open network stream, leave the default options (Radio button UDP selected, port set to 1234) then press OK ( See bellow)
The technique was already illustrated here.
16- Automatically Quit VLC after playing your video!
To quit the vlc after you have played your movie you can simply add vlc://quit to the play list. You can also shutdown the computer, however this is not a feature of vlc. Follow these steps to do so:
- Create a .sh file
- # ! /bin/sh
- vlc && shutdown -h now
17- Play damaged and unfinished videos!
Because VLC is a packet-based media player, it can play the video content of some damaged, incomplete or unfinished videos. This is my favorite feature as I often end up with broken video files due to internet connection issues.
18- Play RAR files!
With VLC you can play videos zipped inside RAR files. VLC has the ability to play series of RAR files all you need to do it to load the very first part like (.part001.rar ). It will automatically take the rest of the parts and play the whole file. You can also use the seek bar!
19- Play ISO files
VLC player also has the ability to use libcdio to access .iso files so that the user can play files on a disk image, even if the user's operating system does not have the capability of working directly with .iso images.
20- Rip DVDs
VLC player includes a basic DVD ripper. This might not be a very attractive feature today nevertheless it seeks to improve with the later versions.
21- Record videos!
With VLC, you can record videos during playback. To do so click on View>Advanced Control to show off the hidden record button. As the button appears you can record video while playing and click the button again to finish recording.
22- Record Live TV!
VLC can also record live TV from a decoder card and act as a sort of mini-DVR in that respect; provided you have TV decoder card.
23-Listen to online radio!
VLC comes with countless shortcuts to radio stations, browse any of your favorite and enjoy it!
Else you can of course always simply find a link to a radio stream and then open it as you would any other network stream in VLC. Enable the shortcuts throughMedia>Services Discovery>Shoutcast radio listings.
24- Play in ASCII mode!
You can playback any video in ascii mode. To enable ASCII mode, open VLC media player and click on Tools>Preferences. Open the section "Video" section and under "Output" select "Color ASCII art video output" from the drop down menu. Save it. Now play any video file to enjoy the ASCII art.
25- Drag and drop files to play in VLC!
VLC is an acronym of VideoLAN Client, however, today VLC is far more than a simple client. VLC can act as streaming server and client . You can set up VLC to stream media from a file or from a DVD as a server, and then another client can stream that media, without having to encode the file first. VLC is the indeed the king of video and audio players and a pride fro opensource community! If you havent yet installed vlc then dont waste time anymore, download it here.


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Tue, Apr 09
In person Group Session - LJUBLJANA - new
Višja Vibracija
Time & Location
Apr 09, 2024, 5:00 PM – 7:00 PM
Ljubljana, C. Andreja Bitenca 68, 1000 Ljubljana, Slovenia
About the event
Kundalini energy healing is a spiritual process, it is a direct energy activation that awakens the powerful healing energy within you. This is a very natural and flowing process. This is intelligence at work to give your system what it needs at the moment. It's a clearing of the pathways as much as possible or as much as you can surrender to at that time. Everyone receives what they are ready for. There is no force.
This is NOT kundalini yoga, kundalini breathwork, or tantra - this is an energy activation that only requires that you surrender to the experience. It's very different from traditional kundalini practices where willful practice is used to raise your energy.
We are born with our life force energy at 100%, but as we pass through life collecting traumas, heartbreaks, and other physical and emotional baggage, we develop energetic blockages. This can cause physical pain, emotional heaviness, anxiety, negative thought patterns, stress, and so much more.
Kundalini energy activation session will awaken your energy so it can flow more fully and clear your blockages. It rewires your energetic system with each repeated session to bring you back to wholeness and alignment and to allow for deep emotional and spiritual healing.
This is pure life-force energy that has incredible intelligence and will do exactly what your system needs at the moment in time.
The total duration of the session will be 2 hours. First, I'll give a bit more detailed information and share potential experiences that you might be having.
- Don't eat anything heavy 2 - 3 hrs before the session
- Wear comfortable clothes and no jewelry
- You can use a sleep mask to cover your eyes and help you drop deeper within. You will need to keep your eyes closed for the whole transmission.
Can't wait to share the life force energy with you!
€50.00Sale ended


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The 10 Biggest Oscar Upsets of All Time
Every year, the Academy Awards are filled with unpredictable twists and turns. Some films sweep ins several categories, while others leave empty-handed. An acting award can go to a pedigreed performer or a newcomer. There's always frontrunners, and sometimes they win. Sometimes, they lose.
When a decision is made that defies expectations, it is known as an upset. Over the decades, the Oscars has seen its fair share of surprise wins and bitter losses. Sometimes these unexpected victories are deserved, while others remain unjustified.
Here are the biggest Oscar upsets in Academy Award history.
The 10 Biggest Oscar Upsets of All Time
Gallery — Terrible Movies That Won Oscars: