Anticipating The FDA's Shift Away From Emergency Approvals
Law360 (July 22, 2021, 5:41 PM EDT) -- Emergency use authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway.
The coronavirus pandemic prompted an unprecedented reliance on emergency use authorizations by the U.S. Food and Drug Administration for a variety of medical devices and treatments.
During a public health emergency, as stated on its website, the FDA can issue EUAs to "allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives."...
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