25 janvier 2023
adelage, « FDA - OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls (Cell and Gene Therapy Catapult - Regulatory Round-up – October 2022) », ELSIBI, ID : 10670/1.ql9pmg
On the 7th of December 2022, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual town hall to answer stakeholder questions related to cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTAT. This event is part of a series to answer questions from stakeholders about a variety of topics on which OTAT has regulatory oversight. Please find details of thi...