Regulatory Blog

The US Food and Drug Administration (FDA) revised its Small Entity Compliance Guide: Safety Reporting Requirements for INDs and BA/BE Studies in October 2026. The guidance helps small businesses understand safety reporting requirements for investigational drugs and biological products under Investigational New Drug (IND) applications and bioavailability (BA) and bioequivalence (BE) studies exempt from IND requirements. The revision updates the history of related guidance docu

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

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on " Clinical trials for medicines: manage...

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...