FDA Draft Bioequivalence Guidance Draws Litany Of Brand Name Complaints
Executive Summary
Brand firms are weighing in on product-specific draft guidance issued by FDA, which the agency hopes will allow generic drug firms to design bioequivalence studies for their ANDAs without having to consult with the Office of Generic Drugs (1"The Pink Sheet" June 11, 2007, In Brief). The draft guidances can be found on 2FDA's Web site