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Last updated 3 days ago
Expanded Access (Compassionate Use) Submission Data
3 days ago
Expanded Access (Compassionate Use) Submission Data
Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting Announcement - 01/26/2023
3 days ago
This is the main page for the CBER Vaccines and Related Biological...
Infectious Disease Tests
3 days ago
Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
Elecsys Chagas
3 days ago
Elecsys Chagas is an in vitro immunoassay for the qualitative detection of...
Application Submissions Guidances
6 days ago
This page lists Application Submissions Guidance documents.
FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
11 days ago
The U.S. Food and Drug Administration today announced 9 voucher recipients under...
ADYNOVATE
12 days ago
Product approval information is indicated for children and adults with hemophilia A...
Section 8000: General Information
12 days ago
This is the main page for CBER's SOPP Section 8000: General Information.
2025 Biological License Application Supplement Noteworthy Approvals
13 days ago
Listing of the 2025 Biological License Application Supplement Noteworthy Approvals
Whole Blood and Blood Components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived)
13 days ago
Treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment
Allovate Therapeutics, LLC - 708912 - 09/30/2025
13 days ago
CGMP/Deviations/Biologics License Application (BLA)