FDA Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry (Catapult’s regulatory round-up – february 2024)
The FDA issued a guidance providing information for industry, researchers, physicians, institutional review boards, and patients about the implementation of FDA’s regulations on charging for investigational drugs under an IND for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect in 2009. FDA has received several questions concerning its implementation of the charging regulation. As a result, FDA issued the guidance for industry “Charging for Investigational Drugs Under IND — Questions and Answers” (June 2016; revised draft August 2022). This guidance finalizes the revised draft guidance of the same title issued in August 2022 and replaces the 2016 guidance.
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 Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry (Catapult’s regulatory round-up – february 2024). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12mif





