Postmarketing Adverse Event Reporting for Medical Products and Dietary – FDA.gov

Docket Number: FDA-2008-D-0610 Issued by:

Guidance Issuing Office

Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition

Office of Clinical Policy and Programs, Center for Drug Evaluation and Research

Office of Clinical Policy and Programs, Center for Devices and Radiological Health

Office of Clinical Policy and Programs, Center for Biologics Evaluation and Research

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDAs intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets ManagementFood and Drug Administration5630 Fishers Lane, Rm 1061Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0610.

03/20/2020

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Postmarketing Adverse Event Reporting for Medical Products and Dietary - FDA.gov