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Guidance Documents/Guidance-Document/Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry

Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

January 28, 2020

January 31, 2020

Center for Biologics Evaluation and Research

39f9f187-0a0c-44a1-8781-ebb975125baa

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