Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
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FDA’s Pepaxto Decider: Peter Marks To Handle Oncopeptides’ Appeal Of Accelerated Approval Withdrawal
CBER director will decide whether the multiple myeloma drug should be withdrawn under new expedited withdrawal procedures; it's the third time FDA leaders have asked senior officials in the biologics center to help decide the fate of a CDER-regulated accelerated approval drug.
Company’s appeal of the US FDA’s formal request to voluntarily withdraw accelerated approval of the multiple myeloma agent is expected to follow the streamlined procedures created in last year’s omnibus legislation, which would preclude a second advisory committee review of melflufen’s fate.
Robert Steinbrook, the 50-year-old health group's third director, plans to stay true to organization’s long-held mission of holding FDA drug approvals to high standards, pushing for stronger evidence of benefit, more attention to safety, and advisory committee votes.