FDA updates adverse event reporting during a pandemic guidance

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic?utm_campaign=FDA%20updates%20adverse%20event%20reporting%20during%20a%20pandemic%20guidance&utm_medium=email&utm_source=Eloqua

FDA updates adverse event reporting during a pandemic guidance

FDA has updated a final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic,” to include information for compounded drugs (see table 1 in the guidance). The guidance provides recommendations to industry regarding adverse event reporting for products during a pandemic.  Please see our website for more FDA guidance related to COVID-19. Please contact compounding@fda.hhs.gov with questions.

For more information, please visit FDA's Human Drug Compounding web site.