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

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