The Foundation for the Accreditation of Cellular Therapy
 
Loading...

Regulatory - U.S Food and Drug Administration

DRAFT GUIDANCE

Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products, March 2009

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) January 16, 2009

Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs), July 2007

GUIDANCE

Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion, November 2009

Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications, October 20, 2009

Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications, October 20, 2009

Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection, August 2009

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, April 2008

Guidance for Industry - Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), August 2007

Guidance for Industry - Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)-Small Entity Compliance Guide, August 2007  

Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container, February 2007

REPORTING

Electronic Biological Product Deviation Reporting (eBPDR) Instructions for Using the eBPDR System, July 11, 2009

Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), March 26, 2008

UPDATES

FDA Update for Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays, August 17, 2009

FDA Update for Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases, August 14, 2009

MEETINGS

Cellular, Tissue and Gene Therapies Advisory Committee (CTGAC) Meeting, May 14 - May 15, 2009

Cellular, Tissue and Gene Therapies Advisory Committee (CTGAC) Meeting, March 29 - March 30, 2007

CONTACT

FDA Biological Product Deviation Contacts