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FDA Releases Guidance on Postmarketing Adverse Event Reporting During a Pandemic

March 22, 2020, Covington Alert

The U.S. Food and Drug Administration (FDA) released guidance on March 19, 2020 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” (Guidance). The Guidance revises FDA’s February 2012 final guidance for industry on adverse event reporting during an influenza pandemic to clarify that the guidance applies to any pandemic, including COVID-19.

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