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US FDA Accelerated Approval Council Required Under Senate User Fee Bill

 
• By Sue Sutter

Intra-agency group would be tasked with ensuring consistent use of the expedited pathway across the FDA, with duties potentially including development of best practices, product review team training, and advising on withdrawals, according to the Senate's bipartisan user fee legislation.

Microphones at table
An intra-agency council comprising at least 10 people would advise on the consistent application of the accelerated approval pathway. • Source: Shutterstock

The US FDA would be required to set up an internal council to ensure consistent application of the accelerated approval pathway under bipartisan user fee legislation introduced in the Senate on 27 May.

The Food and Drug Administration Safety and Landmark Advancements Act (FDASLA), introduced by Health, Education, Labor and Pensions committee...

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