Reforming Accelerated Approval: Three Ideas For Congress
Ideas to reform Accelerated Approval are likely to be debated during the reauthorization of the key US FDA user fee funding authority in 2022. Here are three suggestions for Congress to consider.
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Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
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US FDA Tries To Shape The Accelerated Approval Reform Narrative
Indicating that failure should be expected may be a subtle reminder of the potential consequences of placing more guardrails on the expedited approval pathway.