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Still Mulling EUA Transition Options? Don’t Wait Too Long, Attorney Says

 
• By Elizabeth Orr

Manufacturers whose COVID-19 related products reached market via the US FDA emergency use authorization pathway will soon face a choice as to whether to get additional clearances stay on the market or not. According to Alston and Bird attorney Ben Wolf, the time to prepare is now.

Clocks
• Source: Shutterstock: elwynn

An end to the COVID-19 public health emergency (PHE) may finally be in sight as the Omicron wave recedes and case counts drop across the country. Just a few days ago, 70 Republican members of the US Congress sent a letter to President Joe Biden and secretary of Health and Human Services Xavier Becerra asking the president not to renew the PHE, which will expire in mid-April if not re-upped.

But whenever the PHE ends, manufacturers that have brought regulated products to market through the emergency use authorization (EUA) process...

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More from Policy & Regulation

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
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The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

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