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# Adverse Event Submissions Clarified
- URL: https://www.fdaweb.com/adverse-event-submissions-clarified/
- Published: 2018-05-29T12:00:00.000Z
- Updated: 2026-09-15T00:08:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141545

FDA has issued an online communication to clarify the submission process for expedited serious adverse event (SAE) safety reports from premarket bioavailability/bioequivalence (BA/BE) studies conducted to support development of an ANDA. The [document](http://s2027422842.t.en25.com/e/es?s=2027422842&e=93266&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=9cd60aa32bbb4f95bf85818ef4f0b896&elqaid=3676&elqat=1&ref=fdaweb.com) says that companies with premarket SAE reports from BA/BE studies conducted in the U.S. should submit seven-day and 15-day expedited SAE safety reports and any additional correspondence related to the reports online to [OGD-PremarketSafetyReports@fda.hhs.gov](mailto:OGD-PremarketSafetyReports@fda.hhs.gov).