image credit: The U.S. FDA / Wikimedia

How COVID-19 is Changing FDA Approval and Clearance Processes

September 1, 2020

Via: BioSpace

The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA Approval & Clearance Processes.”

When President Trump’s Operation Warp Speed and the FDA’s emergency use authorizations (EUAs) went into effect, the FDA was inundated with submissions and worked round the clock. Many companies submitting plans for FDA review received turnarounds in 36 hours or less. “There was urgency in the emergency,” Shep Bentley, principal consultant, Bentley Biomedical Consulting, said during the panel discussion. “Now there’s an enormous queue for EUA reviews.”

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