Sponsors of drugs approved through the US Food and Drug Administration’s accelerated pathway could be encouraged to produce high quality confirmatory evidence in a more timely way if the approvals are subject to expiration when the evidence is not presented by a specified deadline, the Institute of Clinical and Economic Review suggests in a new white paper.
Accelerated Approvals Could Have Expiration Dates, Annual Reviews To Promote Confirmatory Trials, ICER Suggests
Institute for Clinical and Economic Review tackles reform of US FDA’s accelerated approval program in white paper responding to payer concerns about managing high-cost drugs supported by limited efficacy data and patient frustrations over possible access restrictions.
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