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# Some Adverse Event Reporting Relaxed Under Pandemic
- URL: https://www.fdaweb.com/some-adverse-event-reporting-relaxed-under-pandemic/
- Published: 2020-03-20T12:00:00.000Z
- Updated: 2026-09-14T16:08:11.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146381

FDA has issued a [guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic?ref=fdaweb.com) entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.” The document discusses situations where medical product adverse event reports could be delayed due to pandemic-related high employee absenteeism. The document says that certain required submissions could be delayed provided that they are submitted within six months of the restoration of reporting processes to their pre-pandemic state. Firms should maintain records to identify what has been stored and when the processes were restored, it says. The guidance does not apply to adverse event reporting by firms that are able to continue reporting operations.

FDA intends to communicate with firms if there are products and issues that present special concerns and for which the agency expects compliance with normal reporting as required by statute and regulation during the pandemic. Special concerns, the agency says, could include:

- product-related safety issues such as (but not limited to) newly emerging safety issues (e.g., an antihypertensive drug associated with liver failure or a non-pandemic-related vaccine associated with anaphylaxis)
- product problems with associated adverse events (e.g., nonfatal serious infections associated with a pre-filled syringe that was recalled due to bacterial contamination)