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FDA Guidance for Industry and FDA Staff Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products

Origin/Publisher:

Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Document Type:
Draft Guidance
Content:
recommendations for applying Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the 21 CFR 1271.10(a)(2) criterion of homologous use.

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