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# Postmarketing Safety Electronic Submission Guidance
- URL: https://www.fdaweb.com/postmarketing-safety-electronic-submission-guidance/
- Published: 2022-04-27T12:00:00.000Z
- Updated: 2026-09-14T17:42:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151685

FDA has published a guidance, *Providing Submissions in Electronic Format—Postmarketing Safety*, providing general information on the electronic submission of specified postmarketing safety reports to CBER and CDER. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-submissions-electronic-format-postmarketing-safety-reports?ref=fdaweb.com) does not apply to vaccines, whole blood or blood components, combination products with a drug or biological product constituent part marketed under a device application, lot distribution reports, and human cells, tissues, and cellular tissue-based products regulated solely under section 361 of the Public Health Service Act.

The guidance contains Introduction; Background; ICSR Submissions; Notification of Receipt of Submissions by FDA; Contingencies When the ESG, FAERS, or SRP is temporarily unavailable; Descriptive Information in Periodic Safety Reports; and Waiver Requests.