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Notices

• Federal Register Notice: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments
  Updated 12/9/2015

• Federal Register Notice: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
  10/30/2015

• Federal Register Notice: Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period
  10/30/2015

• Federal Register Notice: Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period
  10/30/2015

• Federal Register Notice: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
  10/30/2015

• Federal Register Notice: 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
  9/9/2015

• Federal Register Notice: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry
  2/20/2015

• Federal Register Notice: Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance
  12/24/2014

• Federal Register Notice: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance
  12/23/2014

• Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
  Notice; 6/20/2014

• Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System
  3/5/2014

• Guidance for Industry and Food and Drug Administration Staff: IND App for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System
  3/5/2014

• Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Availability
  11/5/2013

• Withdrawn - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells
  8/17/2011

• Clarifying Edits to Existing Special Controls Guidance Documents

Proposed Rules

• Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater; Proposed Rule
  12/21/2020

Final Rules

• Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Final Rule

• Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule

• Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling

• Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation

• Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction

• Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule

• Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule

• Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction

• Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing

• Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing

• Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing