FDA Potency Assurance for Cellular and Gene Therapy Products (From Catapult’s regulatory round-up – January 2024)
The FDA has released a draft guidance on potency assurance for Cell and Gene Therapy Products. This document provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays. The goal of a potency assurance strategy is to ensure that every lot of a product released will have the specific ability or capacity to achieve the intended therapeutic effect. Please submit comments by the 27th of March 2024.
News Published on the 6th of february 2024. Read the entire regulatory round-up for January following this link.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (9 août 2024). FDA Potency Assurance for Cellular and Gene Therapy Products (From Catapult’s regulatory round-up – January 2024). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/125n1





