Generic drug "identical" dosage definition is at FDA's discretion, Pfizer law firm contends.
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).
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