Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
FDA recently issued a draft guidance document on “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” . The FDA guidance provides recommendations for sponsors, clinical investigators, and Institutional Review Boards (IRBs) on defining, identifying, and reporting protocol deviations in clinical investigations. While FDA regulations do not explicitly define protocol deviations or classify […]
