FDA SINGLE-TRIAL EFFICACY GUIDANCE COULD APPLY TO COMPARATIVE TRIALS, AGENCY'S TEMPLE SAYS; CBER AD DIVISION HAS SEEN INCREASE IN COMPETITOR COMPLAINTS
FDA's draft guidance on efficacy standards can be applied to comparative trials between two drugs, Center for Drug Evaluation & Research Associate Director for Medical Policy Robert Temple, MD, said at a Food & Drug Law Institute meeting in Washington, D.C. Sept. 4.
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