1. Pink Sheet

As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions

 
• By Derrick Gingery

Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.

transition
COVID-19 therapeutics with emergency use authorizations must transition to full approval before the public health emergency ends. • Source: Shutterstock

A formal system to ensure COVID-19 therapeutics move from emergency use authorization to full US Food and Drug Administration approval likely will not be implemented within the Center for Drug Evaluation and Research at this time.

A CDER spokesperson told the Pink Sheet that the center wants to ensure they and sponsors maintain the ability to...

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