FDA provides new guidance to industry on manufacture of cell and gene therapy products during COVID-19 pandemic
webmaster2022-05-05T13:20:32+00:00The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight. Cellular therapy products include cellular immunotherapies, cancer vaccines, [...]