Subjects: Cell- and Tissue-Based Therapy - Digital Collections - National Library of Medicine Search Results

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1. Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, November 2022
Subject(s):: Cell- and Tissue-Based Therapy
Clinical Trials as Topic
Genetic Therapy
Government Regulation
United States
United States. Food and Drug Administration

2. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, July 2020
Subject(s):: Biological Products
Tissues
Cell- and Tissue-Based Therapy
Tissue Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.