Clarification of Agenda Item for July 23, 2008 Meeting

It has come to FDA’s attention that there may be a need to clarify the scope of the issues to be addressed during the July 23, 2008, session of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology meeting.  This meeting was announced on June 5, 2008.
73 Fed. Reg. 32030-31.  As described in the notice announcing this meeting, one of the agenda items for the committee on July 23, 2008, is to receive and discuss presentations from the Office of Generic Drugs on the bioequivalence methods for locally acting drug products that treat gastrointestinal (GI) conditions.  The committee will be asked to consider general questions regarding bioequivalence methods for locally acting drugs that treat GI conditions; the committee will not be asked to consider appropriate methodologies for specific drugs that may be members of that class of drug products.