The FDA’s latest guidance outlines crucial considerations for developing Chimeric Antigen Receptor (CAR) T cell products.
Focused on safety, manufacturing, and clinical study design, this guidance addresses the complexity of gene therapy products.
It emphasizes the need for comprehensive product characterization studies, control of critical process parameters, and nonclinical evaluations.
With a thorough overview of early-phase clinical studies, the FDA aims to expedite the clinical development of CAR T cells while ensuring safety, efficacy, and manufacturing feasibility.
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