FDA Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Catapult’s regulatory round-up – february 2024)
The FDA has issued a final guidance to assist registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
Published on the 5th of March 2024 in Catapult’s regulatory round-up for february 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Catapult’s regulatory round-up – february 2024). ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/12mih
