CBER Index

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DACS SC

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

Deviations of Biological Products, Reporting

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

Device Information

DigiFab (Digoxin Immune Fab (Ovine))

Digoxin Immune Fab (Ovine) (DigiFab)

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine (KINRIX)

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

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

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

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix)

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate Vaccine) (Pentacel)

Documents Available from CBER

Donor Screening / HIV

Dryvax (Smallpox Vaccine, Dried, Calf Lymph Type)

Electronic Submissions

E-Mail

Engerix-B (Hepatitis B Vaccine {Recombinant})

Erytype S (Blood Grouping Reagents)

Establishments and Products, Licensed

Exceptions and Alternative Procedures Approved Under 21CFR640.120 (Variances)

Evicel (Fibrin Sealant (Human)

Evithrom (Thrombin, Topical {Human})

Exemptions and Alternative Procedures Under 21 CFR Part 1271.155

Export Certification

Fast Track Designation Request Performance

FDAAA (Food and Drug Administration Amendments Act of 2007)

FDA Modernization Act of 1997 - (FDAMA)

FDA News (Talk Papers)

FDA Patient Safety News

Federal Register
      Federal Register Online via GPO Access
      FDA Federal Register Documents

Females in Clinical Trials

Fibrin Sealant (TISSEEL)

Fibrin Sealant (Human) (ARTISS)

Fibrin Sealant (Human) (Evicel)

Fibrinogen Concentrate (Human) [RiaSTAP]

510(k) Blood Establishment Computer Software

Flebogamma (Immune Globulin Intravenous (Human))

FLU (Influenza Virus Vaccine) Information

Fluarix (Influenza Virus Vaccine)

FluLaval (Influenza Virus Vaccine)

FluMist (Influenza Virus Vaccine, Live, Intranasal)

Fluvirin (Influenza Virus Vaccine)

Fluzone (Influenza Virus Vaccine)

Food and Drug Administration Amendments Act of 2007 (FDAAA)

Forms (FDA Forms Distribution Page for CBER)

Freedom of Information Reading Room

Frequently Asked Questions (FAQs)

 
Updated: January 16, 2009