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USFDA Guidance: Safety Reporting for Investigational Drugs and Devices & Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Safety reporting is one of the most critical safeguards in clinical trials involving investigational drugs and medical devices. To ensure that safety information is collected, evaluated, and communicated effectively, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices (December 2025), and Sponsor Responsibilities — Safety Reporting Requirements and
Sharan Murugan
8 hours ago3 min read