CBER Index
A to C |
D to F |
G to I |
J to M |
N to P |
Q to S |
T to Z
Gamunex - (Immune Globulin Intravenous (Human), 10% by Chromatography Process)
Gene Therapy Patient Tracking System
Genetic Systems HBsAg EIA 2.0 & HBsAg Confirmatory Assay 2.0
(Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal))
Genetic Systems HIV-1/HIV-2 Peptide EIA (Human Immunodeficiency Types 1 and 2 (Synthetic Peptide))
8/22/1997 Supplement
2/9/2000 Supplement
Genetic Systems rLAV (Human Immunodeficiency Type 1)
Guidances / Guidelines
Haemophilus b Conjugate (Meningococcal Protein Conjugate) (COMVAX)
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (ActHIB)
Helixate FS, Kogenate FS (Antihemophilic Factor (Recombinant))
HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine (TWINRIX)
Hepatitis A Vaccine, Inactivated (VAQTA)
Hepatitis B Immune Globulin (Human) (Nabi-HB)
3/24/1999 Application
10/23/2001 Application
Hepatitis B Vaccine (Recombinant) (Engerix-B)
7/7/1998 Supplement
3/28/2000 Supplement
Hepatitis B Vaccine (Recombinant) (Recombivax)
8/27/1999 Supplement
9/23/1999 Labeling Supplement
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) (COBAS Ampliscreen HCV)
Hepatitis C Virus Assay (COBAS AmpliScreen HCV Test)
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) (CHIRON RIBA HCV 3.0 Strip Immunoblot)
Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay (UltraQualä HCV RT-PCR Assay)
Hextend, High Molecular Weight Hydroxethyl Starch 6%
HIV, HTLV and Hepatitis Test Kits
Hot Shot Fuild Warmer
Human Immunodeficiency Virus-1 / Hepatitis C Virus Assay (HIV-1/HCV) (Procleix)
2/27/2002 Application
6/4/2004 Supplement
Human Immunodeficiency Type 1 (Genetic Systems rLAV)
Human Immunodeficiency Virus Type 1 (COBAS AmpliScreen HIV-1 Test)
12/20/2002 Application
12/19/2003 Supplement
Human Immunodeficiency Virus Type 1 Rapid Antibody Test (OraQuick)
11/7/2002 Application
9/5/2003 Supplement
Human Immunodeficiency Virus Type 1/2 Rapid Antibody Test (OraQuick)
3/26/2004 Supplement
3/19/2004 Supplement
Human Immunodeficiency Type 1 (Western Blot) (Cambridge Biotech HIV-1 (Western Blot))
Human Immunodeficiency Type 1 Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay (UltraQual HIV-1 RT-PCR Assay)
Human Immunodeficiency Types 1 and 2 (Synthetic Peptide) (Genetic Systems HIV-1/HIV-2 Peptide EIA)
8/22/1997 Supplement
2/9/2000 Supplement
Human T-Lymphotropic Virus Types I & II (Abbott HTLV-I/HTLV-II EIA)
Human T-Lymphotropic Virus Types I & II (Vironstika HTLV-I/II Microelisa System)
Human T-Lymphotropic Virus Type I p21E Antigen
Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human))
Imciromab pentetate (Myoscint)
Immune Globulin Intravenous (Human) Flebogamma
Immune Globulin Intravenous (Human) (OCTAGAM)
Immune Globulin Intravenous (Human), 10% by Chromatography Process - (Gamunex)
Import Alerts - FDA/ORA Import System
IMx HBsAg (Antibody to Hepatitis B Surface Antigen)
Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
1/29/1997 Application
7/7/2003 Supplement
Information Sheets
Information Page on Influenza Virus Vaccine (FLU)
Influenza Virus Vaccine (Fluzone)
Influenza Virus Vaccine, Live, Intranasal (FluMist)
6/17/2003 Application
11/2/2004 Supplement
Inspection Guides
International Conference on Harmonisation (ICH) Guidances
Investigational New Drug Applications
Isolex 300 & 300i Magnetic Cell Selection System
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