Stacy Cline Amin, former Chief Counsel of the Food and Drug Administration, spoke with Bloomberg Law about how FDA might transition more than 400 products from emergency use status to approved status, if the public health emergency with COVID-19 ends.
“The sheer volume of authorized products could be potentially very disruptive, if not transitioned well by FDA,” said Stacy. “FDA is aware of that and thinking about it.”
The emergency also may not go away anytime soon, with the emergence of new variants and as the pandemic continues to rage globally, Amin noted.
“It may not be the case that the public health emergency for us is really, you know, coming to a quick close,” she said.
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