Regulatory — USA

• AABB - Circular of Information for the Use of Cellular Therapy Products
  www.aabb.org/Documents/About_Blood/Circulars_of_Information/coi_ct0607.pdf

• Code of Federal Regulations


• Good Tissue Practices:
  Human Tissue Intended for Tranplantation
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1270
  Human Cells, Tissues, and Cellular and Tissue-Based Products
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271
  
  
• Good Manufacturing Practices:
  Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=210
  Current Good Manufacturing Practice For Finished Pharmaceuticals
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211
  
  
• Good Manufacturing Practices, Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals:
  www.fda.gov/cber/rules/amendcgmp.htm


• Biologics Products, General:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=600


• Biologics Standards Licensing:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601


• General Biological Standards:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=610


• Medical Devices:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820


• Good Laboratory Practice for Nonclinical Studies:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58


Good Clinical Practices:
www.fda.gov/oc/gcp/regulations.html


• Protection of Human Subjects:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50


• Financial Disclosure by Clinical Investigators:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=54


• Institutional Review Board:
  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56


• Electronic Records; Electronic Signatures:
  www.access.gpo.gov/nara/cfr/waisidx_98/21cfr11_98.html


• Medical Privacy - National Standards to Protect the Privacy of Personal Health Information (Health Insurance Portability and Accountability Act of 1996)
  www.hhs.gov/ocr/hipaa/

• Foundation for the Accreditation of Cellular Therapy (FACT)
  A nonprofit foundation carrying out a voluntary standard-setting, inspection, and accreditation program for cell therapy.
  www.factwebsite.org/

• FDA-CBER
  Center for Biologics Evaluation and Research
  www.fda.gov/cber

• FDA-CBER Compliance Programs
  
  • Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
    www.fda.gov/cber/cpg/7341002tis.htm
  
  
  • Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)
    www.fda.gov/cber/cpg/7342007tis.htm

• FDA-CBER Guidances / Guidelines / Points to Consider - 2007/2008
  
  • Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide
    www.fda.gov/cber/gdlns/hctpcompl.htm
  
  
  • Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
    http://www.fda.gov/cber/gdlns/tissdonor.htm
  
  
  • Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
    http://www.fda.gov/cber/gdlns/pbsc.htm
  
  
  • Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
    http://www.fda.gov/cber/gdlns/kneecart.htm
  
  
  • 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
    http://www.fda.gov/cber/gdlns/hctppool.htm
  
  
  • Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
    http://www.fda.gov/cber/gdlns/cordbldstorII.htm
  
  
  • Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
    http://www.fda.gov/cber/gdlns/cordbld.htm
  
  
  • Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
    http://www.fda.gov/cber/rules/hctdnr.htm
  
  
  • Concerning the June 19, 2007 Final Rule: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing; and Related Labeling
    http://www.fda.gov/cber/rules/hctdnrq&a.htm
  
  
  
• Draft Guidance: Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products
  http://www.fda.gov/cber/gdlns/stercgtp.htm

• FDA-CBER Guidances/Guidelines/Points to Consider
  www.fda.gov/cber/guidelines.htm
  • Guidance for human somatic cell therapy and gene therapy. 1998
    www.fda.gov/cber/gdlns/somgene.pdf
  
  
  
  • Validation of procedures for processing of human tissue intended for transplantation, 2002
    www.fda.gov/cber/gdlns/tissval.pdf
  
  
  
  • Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
    www.fda.gov/cber/gdlns/cmcsomcell.pdf
  
  
  
  • Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
    www.fda.gov/cber/gdlns/gtindcmc.pdf
  
  
  
  • Draft Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice
    www.fda.gov/cber/gdlns/steraseptic.pdf
  
  
  
  • Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
    www.fda.gov/cber/gdlns/clinxeno.pdf
  
  
  
  • Proposed Approach to Regulation of Cellular and Tissue-Based Products
    www.fda.gov/cber/gdlns/celltissue.pdf
  
  
  
  • Health Resources and Services Administration
    www.hrsa.gov

• Good Tissue Practices (GTPs)
  • Suitability determination for donors of human cellular and tissue-based products; proposed rule (1999)
    www.fda.gov/cber/rules/suitdonor.pdf
  
  
  
  • Establishment registration and listing for manufacturers of human cellular and tissue-based products; final rule
    www.fda.gov/cber/rules/frtisreg011901.pdf
  
  

• Good Manufacturing Practices (GMPs), 21 CFR 210 and 211
  www.fda.gov/cder/dmpq/cgmpregs.htm

• NIH Cell Processing Section Master File
  www.cc.nih.gov/dtm/clin_serv/dtm_cell_processing_services_mf_enter.htm

• Good Clinical Practice (GCPs), 1997
  www.fda.gov/cber/guidelines.htm

• ISCT Legal and Regulatory Affairs Committee
  www.celltherapysociety.org/Committees_Working_Groups/Committees/

• Institute of Environmental Sciences and Technology
  www.iest.org/
  • Cleanrooms and associated controlled environments (ISO Standard 14644, Parts 1-8)
    www.iest.org/iso/iso.htm
  
  
  
  • Cleanrooms and associated controlled environments-Biocontamination control (ISO Standard 14698, Parts 1-3)
    www.iest.org/iso/iso698.htm#Anchor-Scope-49575

• NIH Guidelines for Research Involving Recombinant DNA Molecules, 2002
  www4.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlnes_lnk_2002z.pdf

• US Code of Federal Regulations
  www.gpoaccess.gov/cfr/index.html

• US Department of Energy Human Genome Project Gene Therapy information
  www.ornl.gov/TechResources/Human_Genome/medicine/genetherapy.html

• US Federal Register
  www.gpoaccess.gov/fr/index.html

• United States Pharmacopeial Convention (USP)
  www.usp.org
  • Cell and Gene Therapy Products (USP NF 26, 2003, Chapter 1046)
  
  
  
  • Microbial Evaluation of Clean Rooms and Other Controlled Environments (USP NF 26, 2003, Chapter 1116)