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Reforming Accelerated Approval: Three Ideas For Congress

 
• By Michael McCaughan

Ideas to reform Accelerated Approval are likely to be debated during the reauthorization of the key US FDA user fee funding authority in 2022. Here are three suggestions for Congress to consider.

Accelerated Congress
Congress may have to move quickly on accelerated approval reform. • Source: Nielsen Hobbs; the Pink Sheet | Alamy images

Ideas to reform the Accelerated Approval pathway are certain to be debated when Congress works on finalizing the next iteration of user fee funding legislation for the US Food & Drug Administration in 2022.

The topic is almost always on the table anyway, but the controversy over the Accelerated Approval granted to Biogen, Inc./Eisai Co., Ltd.’s Alzheimer’s agent Aduhelm(aducanumab-avwa) has heightened the...

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