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User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals

 
• By Derrick Gingery

Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.

Acceleration
The accelerated approval reforms in the House user fee bill also include a requirement that labels note the product was cleared using the pathway. • Source: Shutterstock

A quicker accelerated approval withdrawal process seems possible under compromise reforms in the draft House US Food and Drug Administration user fee reauthorization bill.

Among the most significant changes to the withdrawal process would be that an advisory committee meeting would only be allowed if requested by the sponsor and “if no such advisory committee has previously advised the Secretary on such issues with respect to the withdrawal of the product prior to the sponsor’s request,” according to the

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