FDA consultation on Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products (Catapult’s regulatory round-up – March 2024)
The FDA has issued a draft guidance which provides recommendations to sponsors who are considering submitting a non-interventional/observational study proposal to the FDA. This draft guidance was developed in response to stakeholders’ growing interest in the potential use of non-interventional/ observational studies to contribute to a demonstration of the effectiveness or safety of a drug.
End date: 19th June 2024
Draft Guidance
Published on the 2nd of April 2024 in Catapult’s regulatory round-up for March 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA consultation on Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products (Catapult’s regulatory round-up – March 2024). ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/12miv
