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From EUA To Full Approval: CDER, CBER Still Developing Transition Plans

 
• By Derrick Gingery

US FDA drug center is evaluating how to handle the end of the coronavirus public health emergency, which would mean unapproved products would no longer be available, but officials likely have plenty of time to consider options.

For Emergency Use Only Sign on Life Buoy with aged sign
EUAs are not intended to be permanent and the FDA is encouraging sponsors using the pathway to work toward full approval of their products. • Source: Shutterstock

Unlike its device-focused colleagues, the US FDA’s Center for Drug Evaluation and Research is not yet sure how it will handle the expiration of the coronavirus-related emergency use authorizations it has issued for drug products.

Emergency use authorizations are not intended to be permanent. Legally, they expire when the public health emergency is declared over or are otherwise revoked. Absent a plan, EUAs for at...

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