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CBER Index

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Abbott HTLV-I/HTLV-II EIA (Human T-Lymphotropic Virus Types I & II)

Acel-Immune (Diphtheria and Tetanus Toxoids and Accellular Pertussis Vaccine)

ActHIB (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Action Plans
      Common Technical Document (CTD) Implementation
      Transmissible Spongiform Encephalopathies (TSE) Action Plan

Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM))

Advertising & Promotional Labeling Letters

Advisory Committees


Alpha-1-Proteinase Inhibitor (Human)
      Alpha-1-Proteinase Inhibitor (Human) (Aralast)
      Alpha-1-Proteinase Inhibitor (Human) (Zemaira)

Alternative Procedures and Exceptions Approved Under 21CFR640.120 (Variances)

Annual Report


Anthrax Vaccine (Biothrax)
      4/29/2004 Supplement
      1/31/2002 Manufacturing Supplement
      1/31/2002 Labeling Supplement

Anti-B (Murine Monoclonal) (Immucor, Inc.)

Antibody to Hepatitis B Surface Antigen (IMx HBsAg)

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) (Genetic Systems Corporation)

Anticoagulant Sodium Citrate 4% w/v Solution, U.S.P.

Anticoagulant Citrate Phosphate Double Dextrose (CP2D) & Additive Solution 3 (AS-3)

Anticoagulant Citrate Dextrose Solution Formula A

Antihemophilic Factor (Human) (Koate-DVI)

Antihemophilic Factor (Recombinant)
      Kogenate FS, Helixate FS

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) (Advate)

Antihemophilic Factor/von Willebrand Factor Complex (Human) (Humate-P)

Anti-thymocyte Globulin (Rabbit) (Thymoglobulin)

Approval Information - Licensed Products

Approval Information by Year

Aralast (Alpha-1-Proteinase Inhibitor (Human))

Autologous Cultured Chondrocytes (Carticel)

Autologous Cultured Chondrocytes (Carticel SM Service)
     8/22/1997 Application
     3/2/2000 Supplement

BabyBIG (Botulism Immune Globulin Intravenous (Human))



Benefix (Coagulation Factor IX (Recombinant)

Biological Product Deviation Reporting

Biomixer 330 & Biomixer 323


Biothrax (Anthrax Vaccine)
      4/29/2004 Supplement
      1/31/2002 Manufacturing Supplement
      1/31/2002 Labeling Supplement

Blood Action Plan

Blood Establishment Computer Software, 510(k)

Blood Establishment Memoranda

Blood Establishment Registration and Product Listing (BER)

Botulism Immune Globulin Intravenous (Human) (BabyBIG)

Bovine Spongiform Encephalopathy (BSE)

Cambridge Biotech HIV-1 (Western Blot) (Human Immunodeficiency Type 1 (Western Blot))

Carticel (Autologous Cultured Chondrocytes)

Carticel SM Service (Autologous Cultured Chondrocytes)
     8/22/1997 Application
     3/2/2000 Supplement

Certiva (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine)

CHIRON RIBA HCV 3.0 Strip (Immunoblot Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA))

Clinical Hold / Refusal to File Meetings

Clinical Investigator Information

Clinical Trials - NIH Clinical Trials Database

Coagulation Factor VIIa (Recombinant) (NovoSeven)

Coagulation Factor IX (Recombinant) (Benefix)

COBAS Ampliscreen HCV (Hepatitis C Virus {Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived})

COBAS AmpliScreen HCV Test (Hepatitis C Virus Assay)

COBAS AmpliScreen HIV-1 Test (Human Immunodeficiency Virus Type 1)
      12/20/2002 Application
      12/19/2003 Supplement

Code of Federal Regulations

Common Technical Document (CTD) Implementation Action Plan

Compliance Actions / Enforcement Actions

Compliance Programs

Computer Software, 510(k) Blood Establishment

COMVAX (Haemophilus b Conjugate (Meningococcal Protein Conjugate)

Conferences / Meetings

Consumer Information

Consumer Round Table Meeting

Countering Bioterrorism

CroFab (Crotalidae Polyvalent Immune Fab (Ovine))

Crosseal (Fibrin Sealant (Human))

Crotalidae Polyvalent Immune Fab (Ovine) (CroFab)


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