FDA Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products (from GCT Catapult’s regulatory round-up for september 2023)
The 21st Century Cures Act (2016) is intended to accelerate medical product development and bring innovations faster and more efficiently to patients. Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act). In accordance with this section, FDA has created a framework for a Real-World Evidence (RWE) Program to evaluate the potential use of RWE in regulatory decision-making for drugs. As part of its RWE Program, the FDA has issued a final guidance document on the use of RWE to help support approval of a new indication for a drug already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support post approval study requirements.
Published on the 30th of August 2023. Please find information on how to submit comments here.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2024). FDA Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products (from GCT Catapult’s regulatory round-up for september 2023). ELSIBI. Consulté le 15 mars 2026 à l’adresse https://doi.org/10.58079/11osr





