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FDA has issued a draft guidance which provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting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 the types of protocol deviations that investigators should report to sponsors and to IRBs
- Recommendations for IRBs in their evaluation of protocol deviations
Comments can be submitted until 28 February 2025.
Published on the 9th of January 2025. Read the entire Regulatory Round-up – December 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (12 février 2025). FDA Protocol deviations for clinical investigations of drugs, biological products, and devices (from Catapult’s regulatory round-up for December 2024). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/13ay2





