Final Guidance on Sponsor Responsibilities
- Jennifer True
- Jan 8
- 2 min read
The FDA issued the final guidance Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies in Dec2025, which replaces the draft guidance issued in 2021 and the final guidance Safety Reporting Requirements for IND and BA/BE Studies (Dec2012) and Safety Assessment for IND Safety Reporting (Dec2015). Some key highlights:- Differentiates Adverse Reactions (AE caused by the drug) versus Suspected Adverse Reaction (reasonable possibility that AE was caused by the drug)- Clarifies that a broader search should be used for Analysis of Similar Events (i.e., for an event of pulmonary embolus include all thrombotic events)- Recommendation to report an observed increase in frequency of AE (versus current labeling) to the manufacturer of a comparator.- Confirmed that results of animal/in vitro studies must only be submitted as IND Safety Reports if suggest a significant risk to humans (not if data is too preliminary to interpret without further evaluation)-Reinforces the need for Safety Surveillance Plans and that these must be available for FDA inspections. It also clarifies that the positions / individuals / entities should be used when describing roles & responsibilities. It also clarifies that related AEs should be examined, as well as data from all available sources (e.g., literature, nonclinical, marketing experience)- Expanded/new language regarding aggregate analyses and the use of independent individuals to conduct unblinding analyses for evaluating increased frequencies of anticipated and expected events. This process should be described in the Safety Surveillance Plan.- Updates the method of reporting to refer to electronic submissions. IND Safety Reports based on aggregate data will still be submitted via eCTD.- Outlines the types of data that should be considered significant and trigger a follow-up IND Safety Reports (change in diagnosis/AE, important change in outcome, autopsy findings, new information that significantly impacts the causality assessment)- For IND Exempt US BA/BE studies, all SAEs must be reported (not just SUSARs)
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