Cell-Based Advanced Therapies and Tissue-Based Products

Guidance for Industry

Cell & Gene, FDA Guidelines

This document is governed by the USP but discusses common cell based and tissue-based therapies.

https://doi.usp.org/USPNF/USPNF_M99766_03_01.html

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U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research

Published June 2015

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