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FDA issues draft guidance regarding confirmatory evidence of clinical trials (from Catapult’s regulatory round-up for september 2023)

FDA has issued a draft guidance Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence that supplements and expands the recommendations in the 2019 Substantial Evidence of Effectiveness draft guidance by providing further detail on the use of data drawn from one or more sources (e.g., clinical data, mechanistic data, animal data) to support the results of one adequate and well-controlled clinical investigation. It also provides examples of types of data that could be considered confirmatory evidence. Importantly, this guidance emphasizes the need for early engagement with the agency for sponsors that intend to establish substantial evidence of effectiveness with one adequate and well-controlled clinical investigation and confirmatory evidence. Details on how to submit comments can be found here.

Published on the 29th of september 2023. Read more of Catapult’s regulatory round-up here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2024). FDA issues draft guidance regarding confirmatory evidence of clinical trials (from Catapult’s regulatory round-up for september 2023). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/11ost


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