FDA Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (Catapult’s regulatory round-up – July 2024)
Diversity Action Plans are intended to increase enrollment of participants who are members of historically underrepresented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended use population. FDA has issued a draft guidance intended to assist sponsors conducting certain clinical studies involving drugs, biological products, and devices to meet requirements for the submission of Diversity Action Plans under section 505(z) and section 520(g)(9) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as added by section 3601 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). Comments can be submitted until 27 September 2024.
Published on the 1st of August 2024 in Catapult’s regulatory round-up for July 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (Catapult’s regulatory round-up – July 2024). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12mjm





