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Guidance Documents/Guidance-Document/Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry

Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 1, 2013

February 3, 2025

Center for Biologics Evaluation and Research

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