FDA PREMARIN BIOEQUIVALENCE STANDARDS SHOULD BE KEPT, KIBBE TELLS HOUSE OVERSIGHT CMTE.; AGENCY SHOULD LIMIT EFFORTS BY INNOVATOR TO DELAY GENERICS
Executive Summary
FDA should stand by its 1991 decision on bioequivalence standards for Wyeth-Ayerst's Premarin, Arthur Kibbe, PhD, Wilkes University, told the House Commerce/Oversight Subcommittee June 19.