CBER Index

Talk Papers (FDA News)

Team Biologics

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use

Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use (DECAVAC)

Tetanus Toxoid Adsorbed

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Adacel)

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Boostrix)

Thimerosal [Mercury]

Thymoglobulin (Anti-thymocyte Globulin (Rabbit))

Thrombin, Topical (Human) (Evithrom)

Thrombin, topical (Recombinant) (RECOTHROM)

TICE BCG (BCG Live)

TISSEEL (Fibrin Sealant)

Tissue Action Plan

Tissue Establishment Registration

Transfer of Therapeutic Products to CDER

Tripedia (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen ORTHO (T. cruzi ELISA Test System)

Tuberculin, Purified Protein Derivative (Aplisol)

Tuberculin, Purified Protein Derivative (Tubersol)

TWINRIX (Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine)

UltraQual HCV RT-PCR Assay (Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay)

UltraQual HIV-1 RT-PCR Assay (Human Immunodeficiency Type 1 Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay)

User Fees - Prescription Drug User Fee Act (PDUFA)

User Fees - Billable Products - Prescription Drug User Fee Act (PDUFA)

Vacancy Announcements

Vaccinia Immune Globulin Intravenous (Human)

Vaccine Adverse Event Reporting System (VAERS)

VAQTA (Hepatitis A Vaccine, Inactivated)

Varicella Virus Vaccine Live (Varivax)

Variances - Exceptions and Alternative Procedures Approved Under 21CFR640.120

Varivax (Varicella Virus Vaccine Live)

vCJD - Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products

VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator; VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack

Vivaglobin - (Immune Globulin Subcutaneous {Human})

Voluven

Warning Letters

West Nile Virus / Blood Safety

West Nile Virus / Nucleic Acid, Pooled Testing/Synthetic [cobas TaqScreen West Nile Virus Test] (cobas TaqScreen West Nile Virus Test for use on the cobas s 201 system)

What's New

WinRho SDF Liquid (Rho(D) Immune Globulin Intravenous (Human))

Withdrawals / Recalls

West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) (Procleix WNV Assay)

Women in Clinical Trials

Xenotransplantation Action Plan

XYNTHA (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)

Yellow Fever Vaccine (YF-Vax)

Zemaira (Alpha-1-Proteinase Inhibitor (Human))

Zoster Vaccine, Live, (Oka/Merck)

Zostavax