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EUA Transition Process: 4 Things FDA Wants You To Know

 
• By Shawn M. Schmitt

A US FDA regulatory expert offers insight into what companies can expect from the agency as it braces to transition potentially hundreds of emergency use authorized (EUA) products to full marketing authorization.

Red and green wooden figures running through a shaker.
• Source: Alamy

The US Food and Drug Administration is bracing for a potential onslaught of companies that will want to transition their emergency use authorized (EUA) products to full marketing authorization.

The FDA has doled out hundreds of EUAs during the COVID-19 pandemic. Some firms may elect to yank their product from shelves when the US public health emergency is declared over, while others will want to make the transition. The agency is working on a high-priority guidance document that will help guide companies that choose to keep their product on the market, post-pandemic

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