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Don’t Expect Abandonment Of US FDA User Fee Programs If They Sunset

 
• By Derrick Gingery

Popular characteristics like goal dates are expected to remain in place if Congress does not renew the user fee programs by 1 October.

peering over cliff
The prospect of a temporary lapse in authorization has stakeholders wondering what happens where the user fees end. • Source: Shutterstock

The worst-case scenario for the US Food and Drug Administration and industry stakeholders is no user fee reauthorization by 1 October, when the current programs expire, but all may not be lost should that day pass without enacted legislation.

Stakeholders believe the user fee programs eventually will be renewed. The bill has long been considered must-pass legislation, since it supports thousands of jobs at the FDA that help drug...

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