FDA Releases Draft Guidance on Development of Genome Editing and CAR T Therapies | Cooley LLP

On March 15, 2022, the US Food and Drug Administration issued a pair of draft guidance documents in the gene therapy space. The first, which is specific to gene therapies incorporating...

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,Drug Administration ,Office Of Tissues ,Investigational New Drug ,Advanced Therapies ,Biologics Evaluation ,Targeted Engagement ,Regulatory Advice ,