CBER Index

A to C | D to F | G to I | J to M | N to P | Q to S | T to Z

Abbott HCV EIA 2.0 (Hepatitis C Virus Encoded Antigen HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant))

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

ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory (Antibody to Hepatitis B Surface Antigen {Mouse Monoclonal IgM}; Antibody to Hepatitis B Surface Antigen {Human}

ABBOTT PRISM HBcore (Hepatitis B Virus Core Antigen {E.coli, Recombinant})

ABBOTT PRISM HCV (Hepatitis C Virus Encoded Antigens {Recombinant c100-3, HCr43, NS5})

ABBOTT PRISM HTLV-I/HTLV-II (Human T-Lymphotropic Virus Types I and II)

ACAM 2000 [Smallpox (Vaccinia) Vaccine, Live]

ActHIB (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Action Plans
      Blood
      Tissue
      Xenotransplantation

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

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

Advertising & Promotional Labeling Letters

Advisory Committees

Afluria (Influenza Virus Vaccine)

ALBAclone (Blood Grouping Reagents)

Albumin (Human) Octapharma Pharmazeutika Produktionsgesm.b.H

Allergenic Extracts (Standardized) Licensed for Distribution in the United States

Allergenics

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

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

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

Annual Report

Anthrax

Anthrax Vaccine

Anti-B (Murine Monoclonal)

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA)/Monoclonal (Auszyme Monoclonal)

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA)

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) (ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory)

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 (Recombinant), Plasma/Albumin Free (XYNTHA)

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

Antihemophilic Factor/von Willebrand Factor Complex (Human) (Alphanate)

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

Anti-Human Globulin (Anti-Human Globulin Solidscreen II)

Anti-thymocyte Globulin (Rabbit) (Thymoglobulin)

Antivenoms - Information on Use and Importation

Aplisol (Tuberculin, Purified Protein Derivative)

Approval Information - Licensed Products

Approval Information by Year

APTIMA HIV-1 RNA Qualitative Assay (Human Immunodeficiency Virus Type 1 {HIV-1 Nucleic Acid Testing/Synthetic})

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

ARTISS (Fibrin Sealant [Human])

ATTENUVAX (Measles Virus Vaccine Live)

Auszyme Monoclonal (Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA)/Monoclonal

Autologous Cultured Chondrocytes (Carticel)

BabyBIG (Botulism Immune Globulin Intravenous (Human))

BCG, Live (TICE BCG)

Benefix (Coagulation Factor IX (Recombinant)

Biological Product Deviation Reporting

Biomixer 330 & Biomixer 323

Bioterrorism

Biothrax (Anthrax Vaccine)

Blood Action Plan

Blood Establishment Computer Software, 510(k)

Blood Establishment Memoranda

Blood Establishment Registration and Product Listing (BER)

Blood Grouping Reagents (ALBAclone)

Blood Grouping Reagents (Erytype S)

Blood Grouping Reagent, Anti-A (Murine Monoclonal); Anti-B (Murine Monoclonal); Anti-A,B (Murine Monoclonal Blend); Anti-D (Monoclonal) (IgM) (Component of Erytype S)

(Blood Grouping Reagent Anti-Fya (Monoclonal) (Seraclone)

Blood Grouping Reagent Anti-s (Monoclonal) (Seraclone)

Blood Grouping Reagent Anti-S (Monoclonal) (Seraclone)

Blood Grouping Reagent Combination Kit

Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

Botulism Immune Globulin Intravenous (Human) (BabyBIG)

Bovine Spongiform Encephalopathy (BSE)

Carticel (Autologous Cultured Chondrocytes)

CEPROTIN (Protein C Concentrate {Human})

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

Cinryze (C1 Esterase Inhibitor (Human)

Clinical Hold / Refusal to File Meetings

Clinical Investigator Information

Clinical Investigator Inspection List

Clinical Trials - NIH Clinical Trials Database

Coagulation Factor VIIa (Recombinant) (NovoSeven)

Coagulation Factor IX (Recombinant) (Benefix)

COBAS AmpliScreen HBV Test (Hepatitis B Virus {Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived})

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

COBAS AmpliScreen HIV-1 Test (Human Immunodeficiency Virus Type 1 {HIV-1 / Polymerase Chain Reaction})

cobas TaqScreen West Nile Virus Test for use on the cobas s 201 system (West Nile Virus / Nucleic Acid, Pooled Testing/Synthetic [cobas TaqScreen West Nile Virus Test])

Code of Federal Regulations
      Biologics Related
      CFR Online via GPO Access

Collaborative Scientific Training Program

Compliance and Surveillance

Compliance Programs

Computer Software, 510(k) Blood Establishment

COMVAX (Haemophilus b Conjugate {Meningococcal Protein Conjugate} and Hepatitis B {Recombinant})

Conferences / Meetings

Consumer & Healthcare Information

Countering Bioterrorism

CroFab (Crotalidae Polyvalent Immune Fab (Ovine))

Crotalidae Polyvalent Immune Fab (Ovine) (CroFab)

Creutzfeldt-Jakob Disease - Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products

 
Updated: October 15, 2008