FDA Releases Draft Guidance on Development of Genome Editing

FDA Releases Draft Guidance on Development of Genome Editing and CAR T Therapies | Cooley LLP

On March 15, 2022, the US Food and Drug Administration issued a pair of draft guidance documents in the gene therapy space.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 ,

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