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FDA Releases Guidance on Postmarketing Adverse Event Reporting During a Pandemic

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  • FDA Releases Guidance on Postmarketing Adverse Event Reporting During a Pandemic

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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