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Oncology Accelerated Approval Re-Reviews: US FDA’s Pazdur Is Not Backing Down

 
• By Michael McCaughan

How has FDA suddenly been able to enforce accelerated approval commitments in oncology? The agency’s Richard Pazdur reflects on lessons from 2021 – and promises more re-reviews to come.

Flipping calendar (Alamy)
ODAC may start having annual meetings about "dangling" accelerated approvals. • Source: Alamy

The US Food and Drug Administration’s Oncology Center of Excellence is planning to make reviews of “dangling” or “delinquent” accelerated approvals a routine agenda topic for the Oncologic Drugs Advisory Committee to build on the momentum toward assuring timely confirmatory study results that it established in 2021.

“This is my Jihad,” OCE Director Richard Pazdur said during a Zoom panel discussion as part of the Prevision Policy/Friends of Cancer Research Biopharma Congress. “It isn’t a momentary, one-year event. It will continue

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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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