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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FDA has issued a draft guidance which provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting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


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