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Where are the IND safety reporting rules, with the timelines?

FDA's guidance, Safety Reporting Requirements for INDs and BA/BE Studies, explains the requirements for reporting safety information during IND studies.

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Official sourceFDAwww.fda.gov
Checked on October 15, 2026

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  • Read Safety Reporting Requirements for INDs and BA/BE Studies.

From the question: Where are the IND safety reporting rules, with the timelines?