FDA Expanded Access to Investigational Drugs for Treatment Use Questions and Answers – Draft Guidance for Industry (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022)
The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now includes new frequently asked questions about how expanded access should be implemented given new regulatory access and statutory requirements through the 21st Century Cures Act (Cures Act) and FDA Reauthorization Act of 2017 (FDARA).
While the guidance remains largely the same from 2017, FDA added new recommendations for Institutional Review Board (IRB) review, informed consent and new requirements in Cures Act and FDARA to publicly share sponsor policies on evaluating and responding to expanded access requests.
See all of Catapult’s Regulatory Round-up for November 2022 here. Published on the 8th of December 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). FDA Expanded Access to Investigational Drugs for Treatment Use Questions and Answers – Draft Guidance for Industry (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022). ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/o67v
