Generic drug "identical" dosage definition is at FDA's discretion, Pfizer law firm contends.
Executive Summary
GENERIC DRUG "IDENTICAL" DOSAGE DEFINITION IS AT FDA's DISCRETION, the Washington, D.C. law firm Wiley, Rein & Fielding said in Feb. 3 comments submitted to FDA on behalf of Pfizer. Congress has delegated to FDA, "exercising considered discretion...to decide when dosage form was identical," Wiley, Rein & Fielding stated. The comments respond to a Nov. 18 letter from the Generic Pharmaceutical Industry Association on the issue of comparability of dosage forms ("The Pink Sheet" Dec. 5, 1994, T&G-10).