Sponsor responsibilities — safety reporting requirements and safety assessment for IND and BA/BE studies

24th December 2025

Sponsor responsibilities — safety reporting requirements and safety assessment for IND and BA/BE studies

Summary: This FDA guidance explains sponsors’ obligations for expedited safety reporting under 21 CFR 312.32 (IND studies) and 21 CFR 320.31(d)(3) (BA/BE studies). It defines key terms and clarifies what should (and should not) trigger an IND safety report, aiming to reduce “over-reporting” of events that do not reflect a real change in risk. A central focus is the need for a systematic approach to safety surveillance, including prospective planning and aggregate analyses of safety data to identify meaningful signals rather than reporting isolated events without context. The guidance also outlines required reporting timeframes, handling of follow-up information, alternative reporting arrangements, and practical recommendations for consistent coding and clear report formatting so investigators and regulators can act quickly when new risks emerge. 

Link: Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies

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