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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: