Accelerated Approval: Adcomm Should Always Precede Withdrawal Proposal, US FDA Says

 
• By Sue Sutter

Convening an advisory committee before a formal proposal to withdraw has been the standard practice to date, but under FDORA it allows the agency to streamline the withdrawal process. The new accelerated approval draft guidance also codifies the practice of tapping other product center leaders to serve as decision-makers in withdrawal disputes.

Skipping rope
The FDA does not want its centers to skip an advisory committee meeting when proposing to withdraw an accelerated approval product. (Shutterstock)

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