FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.
FDA’s Center for Biologics Evaluation and Research (CBER) announced the list of guidance documents it plans on publishing in 2020 that includes nine documents focused on gene therapies. CBER is also planning on guidance for chimeric antigen receptor (CAR) T cell therapies; clinical trial designs; and chemistry, manufacturing, and controls changes, in addition to guidance documents on blood and blood components.
The following are the guidance documents that will address gene therapies:
Source: FDA
INTERPHEX 2025: Critical Role of Walk-In Chambers in Bio/Pharma Development and Manufacturing
April 3rd 2025Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, sat down with the PharmTech Group at INTERPHEX 2025 to discuss the design and critical role of walk-in chambers in the bio/pharmaceutical industry.