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The Investigators' Brochure: a comparison of the draft international conference on harmonisation guideline with current Food and Drug Administration requirements.

For several years, the United States Food and Drug Administration (FDA) has participated in a collaborative effort to harmonize the technical procedures for development and regulatory approval of human pharmaceuticals in multiple countries. This harmonization effort is the work of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). At this point, ICH focuses on achieving harmonization of technical requirements in three major regions of the world, i.e., the United States, European Union, and Japan. One area for which harmonization is being sought is the format and content of the Investigators' Brochure. On October 27, 1993, the ICH Steering Committee agreed that the ICH draft guideline on the Investigators' Brochure should be made available for public comment. On August 9, 1994, the FDA published the draft guideline for the format and content of the Investigators' Brochure. This draft guideline was prepared by the Efficacy Expert Working Group of the ICH. FDA solicited written comments on this draft guideline until October 11, 1994. Ultimately, FDA intends to adopt the ICH Steering Committee's final guidelines on Investigators' Brochures as part of a larger document on good clinical practices. Therefore, the content of this draft guideline warrants careful attention. In this paper, ICH's proposed information for inclusion in the Investigators' Brochure is reviewed and compared with current regulatory requirements of FDA. The expanded contents of the Investigators' Brochure proposed by ICH, which represent potential new requirements beyond current FDA regulations, are highlighted. The major controversial elements of this draft guideline are summarized.