• Approval Information (Labels and Reviews)
• Lettersto Industry, Healthcare Providers, and Clinical Investigators
• PrescriptionDrug User Fee Act (PDUFA) Billable Products  (updated 9/28/2007)
• Recallsand Withdrawals
• ResearchDivisions and Investigators
• TalkPapers
• Safety Information
• ViolativeAdvertising and Promotional Labeling Letters
• Frequently Asked Questions About Therapeutic Biological Products
• Important Addresses
  • Investigational New Drug Applications 
  • Required Postmarketing Adverse Experience Information
  • Advertising and Promotional Labeling
  • Reports of Biologic Product Deviations
  • Biologic License Applications (BLAs), BLA Supplements, Annual Reports on Postmarketing Studies, Postmarketing Study Final Reports, Postmarketing Study Correspondence, and Distribution Reports

On October 1, 2003, FDA transferred certain product oversight responsibilities from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). This consolidation provides greater opportunities to further develop and coordinate scientific and regulatory activities between CBER and CDER, leading to a more efficient, effective, and consistent review program for human drugs and biologics. FDA believes that as more drug and biological products are developed for a broader range of illnesses, such interaction is necessary for both efficient and consistent agency action. Under the new structure, the biologic products transferred to CDER will continue to be regulated as licensed biologics.

To see which product classes have been transferred and which will remain at CBER, please refer to Transfer of Therapeutic Products to the Center for Drug Evaluation and Research.

The therapeutic biological products now under CDER's review include:

• Monoclonal antibodies for in-vivo use
• Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
• Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
• Other non-vaccine therapeutic immunotherapies

OFFICE OF DRUG EVALUATION I
RESPONSIBLE OFFICE/DIVISION	INDICATION	PRODUCT
Division of Cardiovascular and Renal Products	Renal Disorders Cardiology Disorders Arterial Vascular Disorders	Activase [Alteplase] Cathflo Activase [Alteplase] ReoPro [Abciximab] Retavase [Reteplase] Streptase [Streptokinase] TNKase [Tenecteplase]
Division of Neurology Products	Neurology Peripheral neuropathy  (not intrinsically painful neuropathies)	Avonex [Interferon beta-1a] Betaseron [Interferon beta-1b] Botox [Botulinum Toxin Type A] Myobloc [Botulinum Toxin Type B] Rebif [Interferon beta-1a] Tysabri [Natalizumab]
Division of Psychiatry Products	-----------------	-----------------

 

OFFICE OF DRUG EVALUATION II
RESPONSIBLE OFFICE/DIVISION	INDICATION	PRODUCT
Division of Metabolism and Endocrinology Products	Endocrine Bone related (osteoporosis, surgery and other bone repair)	-----------------
Division of Pulmonary and Allergy Products	Allergy Pulmonary	Pulmozyme [Dornase alfa] Xolair [Omalizumab]
Division of Anesthesia, Analgesia and Rheumatology Products	Rheumatology Pain treatment (including peripheral neuropathies that are intrinsically painful)	Enbrel [Etanercept] Humira TM [Adalimumab] Kineret [Anakinra] Orencia [Abatacept] Remicade [Infliximab]

   

OFFICE OF DRUG EVALUATION III
RESPONSIBLE OFFICE/DIVISION	INDICATION	PRODUCT
Division of Reproductive and Urologic Products	Urologic Reproductive	-----------------
Division of Gastroenterology Products	Gastrointestinal (includes non-viral hepatic disorders) Genetic metabolic (inborn) disorders Large volume parenterals	Aldurazyme [Laronidase] Fabrazyme [Agalsidase beta] Naglazyme [Galsulfase]
Division of Dermatology and Dental Products	Dental Dermatology	Alferon N Injection [Interferon alfa-n3] Amevive [Alefacept] Raptiva [Efalizumab] Regranex [Becaplermin] Santyl [Collagenase]

 

OFFICE OF ANTIMICROBIAL PRODUCTS
RESPONSIBLE OFFICE/DIVISION	INDICATION	PRODUCT
Division of Anti-Infective and Ophthalmology Products	Bacterial infectious disease Sepsis Ophthalmology	Xigris [Drotrecogin alfa (activated)]
Division of Special Pathogen and Transplant Products	Solid organ transplant Immunodeficiency white cell disorders Special pathogens (e.g., fungal, TB, Anthrax)	Actimmune [Interferon gamma-1b] Orthoclone [Muromonab-CD3] Simulect [Basiliximab] Zenapax [Daclizumab]
Division of Antiviral Products	Viral infections, including viral hepatitis	Copasys Copegus [Peginterferon alfa-2a] Infergen [Interferon alfacon-1] Intron A [Interferon alfa-2b] Pegasys [Peginterferon alfa-2a] Peg-Intron [Peginterferon alfa-2b] Roferon-A [Interferon alfa-2a] Synagis [Palivizumab]

   

OFFICE OF ONCOLOGY DRUG PRODUCTS
RESPONSIBLE OFFICE/DIVISION	INDICATION	PRODUCT
Division of Drug Oncology Products	All small molecule cancer treatments Consolidated from many different divisions Cancer Prevention	-----------------
Division of Biologic Oncology Products	Biologic cancer treatments Biologic cancer ancillary treatments All biologics for GVHD (all cause transplants)	Avastin [Bevacizumab] Bexxar [Tositumomab] Campath [Alemtuzumab] Elitek [Rasburicase] Elspar [Asparaginase] Eribitux [Cetuximab] Herceptin [Trastuzumab] Kepivance [Palifermin] Leukine [Sargramostim] Neulasta [Pegfilgrastim] Neumega [Oprelvekin] Neupogen [Filgrastim] Oncaspar [Pegaspargase] Ontak [Denileukin diftitox] Proleukin [Aldesleukin] Rituxan [Rituximab] Zevalin [Ibritumomab tiuxetan]
Division of Medical Imaging and Hematology Products	Diagnostic imaging Hematology Venous vascular disorders	Abbokinase [Urokinase] Aranesp [Darbepoetin alfa] CEA-Scan TM [Arcitumomab] Epogen [Epoetin alfa] NeutroSpec [Technetium fanolesomab] Procrit [Epoetin alfa] ProstaScint [Capromab Pendetide] Verluma [Nofetumomab]

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