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# Guide on Drug Study Safety Reporting Requirements
- URL: https://www.fdaweb.com/guide-on-drug-study-safety-reporting-requirements/
- Published: 2021-06-25T12:00:00.000Z
- Updated: 2026-09-14T17:04:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149623

FDA has posted a [draft guidance](https://www.fda.gov/media/150356/download?ref=fdaweb.com) on *Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies*. The document provides recommendations to help sponsors comply with the expedited safety reporting requirements under an IND or as part of a bioavailability or bioequivalence study that is exempt from IND requirements. It defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors.

The agency says the guidance also merges content from the final guidance entitled *Safety Reporting Requirements for INDs and BA/BE Studies* (12/2012) and from the draft guidance entitled *Safety Assessment for IND Safety Reporting* (12/2015). It includes revised recommendations initially described in the 2015 draft guidance on the following topics: (**1**) planned unblinding of safety data and implications for trial integrity; (**2**) increased flexibility regarding the party 37 reviewing aggregate safety information for IND safety reporting purposes; (**3**) clarification regarding the scope and methodology of aggregate analyses; and (**4**) clarification regarding the plan for safety surveillance, including what elements should be included in the plan.

The 2015 draft guidance has been withdrawn upon the publication of this guidance.