INDIVIDUAL BIOEQUIVALENCE TESTING FOR GENERICS AND POSTAPPROVAL CHANGES BEING PROPOSED IN FDA DRAFT GUIDANCE; OUTSIDE EXPERT PANEL USED TO DEVELOP POLICY
Executive Summary
An individual bioequivalence approach will be proposed for generic drugs and postapproval changes of all drugs in an upcoming draft guidance, Individual Bioequivalence Working Group Chair Mei-Ling Chen, PhD, told the Pharmaceutical Science Advisory Committee at its May 7 meeting.