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FDA Scraps Trump-Era Leeway for Lab Test Authorizations

Law360

15 Nov 2021

Stacy Cline Amin spoke to Law360 about the U.S. Department of Health and Human Services dropping a Trump-era decision that said the Food and Drug Administration (FDA) didn’t have to require premarket review of lab-developed COVID-19 tests.

“This withdrawal is a long time coming, but you can tell from how thoughtful and thorough the guidance is that it took a long time to develop,” Stacy said. “Looking beyond COVID-19, I anticipate that both FDA and the industry will pivot now to focus on legislation that will provide long-term certainty and clarity to test developers.”

Read the full article.

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