Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

 
• By Derrick Gingery

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

FDA entrance sign 2016
The 2020 transition for insulin and other products from drug to biologics regulation still worries legislators and others. • Source: Shutterstock

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