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Home » User Fee Hearing Highlights Confirmatory Studies for Drugs That Get Accelerated Approval
User Fee Hearing Highlights Confirmatory Studies for Drugs That Get Accelerated Approval
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni fielded questions from lawmakers yesterday on confirmatory trials for drugs that receive FDA’s accelerated approval, during a hearing on reauthorizing user fee programs for prescription drugs, generics and biosimilars.