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  4. RFD Jurisdictional Decisions
  5. Capsular Decisions - Products Assigned to CBER
  1. RFD Jurisdictional Decisions

Capsular Decisions - Products Assigned to CBER

A. Biological Products

  • Interleukin for treatment of HIV and cancer*
  • Hemostasis-factor based hemostatic agent
  • Protein to maintain normal intestinal microflora*
  • Synthetic protein for treatment of anemia*
  • Plasmid vectored gene silencing to treat hepatitis
  • Autologous cultured chondrocytes for cartilage repair
  • Recombinant human protein to treat infection*
  • Enzyme replacement therapy for Fabry disease*
  • Immune globulin treatment for autoimmune skin disease
  • Recombinant protein to treat bone diseases*
  • Cancer vaccine and antibody for treatment of melanoma
  • Antigenic modification of autologous blood for allergy treatment

B. Devices

  • Device to process autologous cells for wound treatment
  • Device to facilitate autograft transplantation
  • Device to concentrate a therapeutic protein from autologous blood
  • Device to prepare autologous fibrin sealant
  • In vitro test kit to identify and enumerate CD34+ cells
  • Device to determine concentration of CD34+ cells in peripheral blood and apheresis products
  • In vitro urine test to aid in clinical diagnosis of HIV infection
  • Immunodiagnostic assay for HIV (for individual patient use)
  • Branched DNA technology-based quantification assay for HIV (for patient management)
  • Device to inactivate pathogens in blood
  • Device to modify blood cells

C. Drugs

  • Sodium citrate solution to prevent coagulation during blood collection and storage
  • Citrate-dextrose solution to prevent coagulation during extracorporeal blood processing
  • Contrast agent-drug combination for tracking cells in cell therapy studies

D. Tissues

  • Fascia lata particles for surgical use

E. Combination Products with Biological Product Primary Mode of Action

  • Biological product with implantable delivery device*
  • Cellular transplant for diabetes treatment
  • Biological hemostatic agent with reconstitution and delivery devices
  • Fibrin sealant and delivery catheter
  • Interferon and injector for treatment of hepatitis C*
  • Injectable protein with delivery device for orthopedic use*
  • Drug/biologic embolization agent
  • Autologous cellular product and delivery device
  • Radiolabeled antibody with detector device*
  • Autologous cellular therapy and delivery device to treat cardiovascular disease
  • Autologous cells and scaffold for orthopedic use
  • Blood-derived protein and delivery device/dressing for wound treatment
  • Menstrual tampon with bacteria to restore/maintain natural vaginal flora
  • Autologous cells and scaffold for organ replacement
  • Pegylated interferon and ribavirin to treat chronic hepatitis C*
  • Interferon and drug to treat chronic hepatitis C*
  • Blood-derived hemostatic agent and applicator
  • Device and biologic to separate stem cells for reinfusion after chemotherapy
  • Tumor-derived antigens for diagnostic use
  • Recombinant growth factor and delivery vehicle*
  • Monoclonal antibodies and magnetic microspheres to remove tumor cells from bone marrow
  • Cultured bone marrow cells and bone void filler with handling agent for bone repair
  • Autologous blood, light source, and photosensitizing agent for immunotherapy
  • Gene therapy and drug for treatment of malignant glioma
  • Autologous chondrocytes and scaffold for repair of cartilage defects
  • Autologous mesenchymal cells and scaffold for diaphragm repair

* On June 30, 2003, FDA transferred responsibility for the regulation of certain therapeutic biological products from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). Accordingly, the persons charged with premarket review of these products are now located within CDER, not CBER, and certain products transferred at the same time FDA transferred this responsibility. It should be noted that some of the therapeutic biological products identified as being assigned to CBER at the time the RFD determination was made are now assigned to CDER. More information about the transfer can be found on the Jurisdictional Transfers section of the Combination Products website.

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