Regulatory Blog

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

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...