FDA Protocol deviations for clinical investigations of drugs, biological products, and devices (from Catapult's regulatory round-up for December 2024)

FDA has issued a draft guidance which provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. This guidance includes the following: Definitions for protocol deviations and important protocol deviations Recommendations on the types of protocol deviations that sponsors should report to FDA in clinical study reports for drugs and devices Recommendations on ...