FDA "INDIVIDUAL" BIOEQUIVALENCE APPROACH SHOULD AWAIT DATA ON CURRENT STANDARD, COMMITTEE MEMBERS SAY; STUDIES SHOULD FOCUS ON GENERAL POPULATION
FDA should collect data evidencing problems with the average bioequivalence methodology for determining therapeutic equivalence between generic and innovator drugs before recommendations on the agency's individual bioequivalence proposal can be made, several members of the Advisory Committee for Pharmaceutical Science (formerly the Generic Drugs Advisory Committee) told FDA at an Aug. 15 meeting.
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