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FDA GUIDANCE · FINALDecember 15, 2025

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Guidance for Industry

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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
Device & Drug Safety
Issue date
December 15, 2025
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