FDA GUIDANCE · FINALOctober 19, 2026

Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Generic Drugs, Good Clinical Practice (GCP), Safety - Issues, Errors, and Problems

Issue date

October 19, 2026

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