FDA: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements
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 events2 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.