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Executive Summary

Three academic experts in the field of bioequivalence testing will serve as referees during FDA's three-day workshop on bioequivalence issues beginning Sept. 29. The three members of the panel of expert consultants will be: William Barr, PhD, Chairman and Professor of Pharmacy and Pharmaceutics at the Medical College of Virginia; Edward Garrett, PhD, Graduate Research Professor in Pharmaceutics at the University of Florida; and Milo Gibaldi, PhD, Dean of the University of Washington School of Pharmacy. All three have written extensively on bioequivalence-related topics, and all three have served as consultants to the pharmaceutical industry and FDA. The role of the expert consultants will be to serve as designated questioners, since the size of the hearing -- which will be attended by aproximately 800 people -- precludes opportunities for questions from the floor. The expert consultants will be responsible for asking speakers to clarify or expand upon points made during their presentations. In addition, FDA officials will also be able to raise points for clarification. During the three-day hearing, over 40 different speakers will make presentations. Many of FDA's senior drug regulatory officials will also be participating in the proceedings as chairpersons for the meeting, which is organized into six half-day sessions. FDA Commissioner Young will make remarks at both the opening and closing of the hearing. Young and Deputy Commissioner John Norris are serving as overall hearing chairman. Individual session chairpersons include Office of Drug Research and Review Director Robert Temple, MD; Division of Bioequivalence Director Shrikant Dighe, PhD; and Office of Drug Standards Deputy Director James Morrison. Office of Drug Standards Director Peter Rheinstein, MD, has been the lead FDA organizer of the hearing. Rheinstein, in a recent letter to interested parties, noted that since an original Federal Register announcement of the meeting in June, FDA had changed the official appellation of the meeting from "workshop" to "hearing." The reason was "to emphasize that the meeting is not intended to be an educational program, but instead an opportunity for all interested parties to express their views on the requirements FDA imposes for a finding of bioequivalence between immediate release solid oral dosage forms." The degree of commitment of top agency staff time underscores the significance FDA is placing on the hearing. The agency will make a transcript of the proceeding available, probably in November. After that, the agency will create a docket, and for a 60-day period after the transcript becomes available FDA will accept written comments on the proceedings. The agency will then begin to evaluate both the oral presentations and subsequent written submissions to determine if FDA's current bioequivalence regulations need to be modified.

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