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

• 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
  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  • Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug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  • Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New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  • Draft Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice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)