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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
Dec 20, 20253 min read
UK MHRA Guidance: Managing Clinical Trial Authorisations & Safety Reporting (Updated 2025)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on " Clinical trials for medicines: manage...
Sharan Murugan
Feb 9, 20252 min read
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...
Sharan Murugan
Apr 20, 20242 min read