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

Ombudsman

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)

Pandemic Influenza

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)

Pediatrics

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])

Product Deviation Reporting

Product Information

Product Shortage Information

Products and Establishments, Licensed

Products - Transfer of Therapeutic Products to CDER

Proposed / Final Rules

ProQuad - Measles, Mumps, Rubella and Varicella Virus Vaccine Live

Protein C Concentrate (Human) (CEPROTIN)

Public Inquiries