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GUIDANCE DOCUMENT

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic February 2012

Final
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 Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Devices and Radiological Health
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. FDA anticipates that during an influenza 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 influenza may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during an influenza pandemic.


Submit Comments

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 Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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