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                Biologics Guidances

Biologics Guidances

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Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry
	10/2023 (Updated November 27, 2023)
	Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide; Guidance for Industry
	11/2022
	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
	7/2020
	Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry
	Updated 5/2018 - This document supersedes the guidance of the same title dated March 2016.
	Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Guidance for Industry
	11/2017
	Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271; Guidance for Industry
	9/2017
	Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Product s (HCT/Ps) ; Guidance for Industry
	9/2016. Corrected 5/2017. This document supersedes the draft guidance of the same title dated December 2015.
	Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry
	11/2016
	Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry
	8/2016
	Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271 - Guidance for Industry
	3/2016
	Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry
	9/2015
	Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirement for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
	12/2011
	Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests
	4/2008
	Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
	8/2007
	Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) - Manufacturing Arrangements
	9/2006
	Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
	11/2004
	Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation
	3/2002

                                                                                  Content current as of:
      11/27/2023
              
              
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                        Allergenics Guidances
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