CBER Index
Nabi-HB (Hepatitis B Immune Globulin (Human )
NDA Product Approval Information
Notice of Initiation of Disqualification Proceedings Letters
Notification Process for Transfusion Related Fatalities and Donation Related Deaths
NovoSeven (Coagulation Factor VIIa (Recombinant)
OCTAGAM (Immune Globulin Intravenous (Human))
OLYMPUS PK System Blood Grouping and Phenotyping Reagents
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
OraQuick Rapid HIV-1 Antibody Test
ORTHO T. cruzi ELISA Test System (Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen)
Patient Safety News (FDA)
PAKAUTO Platelet Antibody Screening Test
Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined)
Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)(Prevnar)
Pneumococcal Vaccine, Polyvalent (Pneumovax 23)
Pneumovax 23 (Pneumococcal Vaccine, Polyvalent)
Poliovirus Vaccine Inactivated (Monkey Kidney Cell) (IPOL)
Postmarketing: Report to Congress: Reports on Postmarketing Studies [FDAMA 130]
Postmarketing Study Commitments
Pregnancy and Lactation Labeling
Prescription Drug Marketing Act - (PDMA)
Prescription Drug User Fee Act - (PDUFA)
Prescription Drug User Fee Act (PDUFA) - Billable Products
Premarket Approval - Devices -Approval Information
Presentations / Summaries from Meetings
Prevnar (Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein)
Privigen (Immune Globulin Intravenous {Human}, 10% Liquid)
Procleix HIV-1/HCV Assay (Human Immunodeficiency Virus Type 1 and / or Hepatitis C Virus [HIV-1 and Hepatitis C Virus / Nucleic Acid Pooled Testing / Synthetic])
Procleix Ultrio Assay (Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus [HIV-1 and Hepatitis C Virus and Hepatits B Virus/Nucleic Acid Pooled Testing/Synthetic])
Procleix West Nile Virus (WNV) Assay (West Nile Virus [WNV/Nucleic Acid Pooled Testing/Synthetic])
Products and Establishments, Licensed
Products - Transfer of Therapeutic Products to CDER
ProQuad - Measles, Mumps, Rubella and Varicella Virus Vaccine Live
Protein C Concentrate (Human) (CEPROTIN)