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Guidance Documents/Guidance-Document/S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS: Guidance for Industry

S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS: Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

May 1, 2023

May 2, 2023

Center for Drug Evaluation and Research

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