CBER Index
A to C |
D to F |
G to I |
J to M |
N to P |
Q to S |
T to Z
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
Blood
Common Technical Document (CTD) Implementation
Device
Tissue
Transmissible Spongiform Encephalopathies (TSE) Action Plan
Xenotransplantation
Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM))
Advertising & Promotional Labeling Letters
Advisory Committees
Allergenics
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
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)
ReFacto
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))
BCG, Live (PACIS)
BCG Live (TICE BCG)
Benefix (Coagulation Factor IX (Recombinant)
Biological Product Deviation Reporting
Biomixer 330 & Biomixer 323
Bioterrorism
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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