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# Pandemic Adverse Event Reporting Guidance
- URL: https://www.fdaweb.com/pandemic-adverse-event-reporting-guidance/
- Published: 2020-05-20T12:00:00.000Z
- Updated: 2026-09-14T16:15:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146821

FDA has issued a guidance, *Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic*, with recommendations for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. The [document](https://www.fda.gov/media/72498/download?ref=fdaweb.com) says the agency anticipates that during the current pandemic industry and FDA workforces may be reduced due to high employee absenteeism, while reporting of adverse events related to the widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase.

“This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic,” the document says. FDA says it believes this approach will make it possible for firms with reporting responsibilities to focus their limited resources on these types of reports: 

- reports related to medical products indicated for treating or preventing the pathogen causing the pandemic;
- other reports indicated in the guidance; and
- reports on products presenting special concerns as specified by FDA.

FDA says it is revising and replacing a 2012 guidance on adverse event reporting during an influenza pandemic to clarify that it is applicable to any pandemic.