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# IND-Exempt BA/BE Study Guidance
- URL: https://www.fdaweb.com/ind-exempt-ba-be-study-guidance/
- Published: 2022-08-02T12:00:00.000Z
- Updated: 2026-09-14T17:54:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152420

FDA has published a draft guidance, *Electronic Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies*, containing instructions for the electronic submission of expedited individual case safety reports (ICSRs) from IND-exempt bioavailability/bioequivalence studies through the FDA adverse event reporting system database. The [document](https://www.fda.gov/media/160561/download?ref=fdaweb.com) says an ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product.

“The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submission,” the draft says.