- Importance of Influenza Vaccination for Health Care Personnel
- Kogenate FS [Antihemophilic Factor (Recombinant]
- Cinryze (C1 Esterase Inhibitor (Human)
- Influenza Virus Vaccine 2008-2009 Season
- GARDASIL (Human Papillomavirus Vaccine)
- Zostavax (Herpes Zoster Vaccine)
- Advisory Committees
- Blood Establishment Registration
- Certification to Accompany Biological Product Submissions
- Forms
- Guidances/Guidelines/Points to Consider
- Impact of Severe Weather Conditions on Biological Products
- Proposed and Final Rules
- Human Cell and Tissue Establishment Registration
- Recall & Product Withdrawals
- Reporting Adverse Events and Product Deviations
- Safety Information
- Shortages
SOPP 8006: Resolution of Differences in Scientific Judgement in the Review Process - Update
Posted: 1/23/2009
Posted: 1/23/2009
Approval Information: Influenza Virus Vaccine (Afluria) - Annual Progress Report of Postmarketing Studies
Posted: 1/23/2009
Approval Information: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) - Summary Basis for Approval
Posted: 1/23/2009
Approval Information: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Adacel)
Posted: 1/22/2009
Draft Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
Posted: 1/22/2009
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule
Posted: 1/21/2009
Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs Improving Human Subject
Protection
Posted: 1/21/2009
Untitled Letter: Blood and Rapid HIV Test, iDiagnostics
Posted: 1/21/2009
Untitled Letter: HIV Test Kit, ECOMM LOGIC LLC
Posted: 1/21/2009
FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect
Posted: 1/21/2009
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