CBER Index
A to C |
D to F |
G to I |
J to M |
N to P |
Q to S |
T to Z
Nabi-HB (Hepatitis B Immune Globulin (Human )
3/24/1999 Application
10/23/2001 Application
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))
Ombudsman
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
6/22/2004 Supplement
3/26/2004 Supplement
3/19/2004 Supplement
OraQuick Rapid HIV-1 Antibody Test
11/7/2002 Application
9/5/2003 Supplement
PACIS (BCG, Live)
PAKAUTO Platelet Antibody Screening Test
Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined)
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)(Prevnar)
2/17/2000 Application
10/01/2002 Supplement
Pooled Plasma, Solvent Detergent Treated (VIPLAS/SD, PLAS+SD)
Postmarketing: Report to Congress: Reports on Postmarketing Studies [FDAMA 130]
Postmarketing Study Commitments
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 CRM197 Protein)
2/17/2000 Application
10/01/2002 Supplement
Procleix (Human Immunodeficiency Virus-1 / Hepatitis C Virus Assay (HIV-1/HCV))
2/27/2002 Application
6/4/2004 Supplement
Product Deviation Reporting
Product Information
Product Labeling
Product Shortage Information
Products and Establishments, Licensed
Products - Transfer of Therapeutic Products to CDER
Proposed / Final Rules
Publications
Public Inquiries
|
