Unofficial FDA What's New: Vaccines, Blood and Biologics Bot
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Posts from the FDA What's New: Vaccines, Blood and Bioligics. Not affiliated with the FDA. Bot will update once/day at midnight CST. For any questions, feature requests, or bug reports, please reach out to
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Medical Product Development Tools at FDA
February 6, 2026 at 6:00 AM
Medical Product Development Tools at FDA
BK251168- Precise Cell Concentration System
February 6, 2026 at 6:00 AM
BK251168- Precise Cell Concentration System
CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
February 4, 2026 at 6:00 AM
CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
February 4, 2026 at 6:00 AM
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
FDA Grand Rounds – Postmarket Regulation of Cosmetic Products: The Who, What, When, Why and How - 02/05/2026
January 31, 2026 at 6:00 AM
FDA Grand Rounds – Postmarket Regulation of Cosmetic Products: The Who, What, When, Why and How - 02/05/2026
A Special Year, New Seal, and Renewed Commitment to the American People
January 29, 2026 at 6:00 AM
A Special Year, New Seal, and Renewed Commitment to the American People
Charter of the Vaccines and Related Biological Products Advisory Committee
January 28, 2026 at 6:00 AM
Charter of the Vaccines and Related Biological Products Advisory Committee
What Does FDA Approve? Part 2
January 28, 2026 at 6:00 AM
What Does FDA Approve? Part 2
FluMist Quadrivalent
January 27, 2026 at 6:00 AM
FluMist Quadrivalent
ProDx Health - 720762 - 01/08/2026
January 22, 2026 at 6:00 AM
ProDx Health - 720762 - 01/08/2026
Genetrace - 720529 - 01/08/2026
January 22, 2026 at 6:00 AM
Genetrace - 720529 - 01/08/2026
Genovate - 720554 - 01/08/2026
January 22, 2026 at 6:00 AM
Genovate - 720554 - 01/08/2026
Germaphobix - 720555 - 01/09/2026
January 22, 2026 at 6:00 AM
Germaphobix - 720555 - 01/09/2026
FDA Grand Rounds – Antibody Glycosylation Insights for High-Quality Biotherapeutics - 01/22/2026
January 17, 2026 at 6:00 AM
FDA Grand Rounds – Antibody Glycosylation Insights for High-Quality Biotherapeutics - 01/22/2026
Guiding Principles of Good AI Practice in Drug Development
January 15, 2026 at 6:00 AM
Guiding Principles of Good AI Practice in Drug Development
Cellular & Gene Therapy Products
January 12, 2026 at 6:00 AM
Cellular & Gene Therapy Products
FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
January 12, 2026 at 6:00 AM
FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2026
January 10, 2026 at 6:00 AM
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2026
2026 Safety and Availability Communications
January 10, 2026 at 6:00 AM
2026 Safety and Availability Communications
BK251245- Procleix® WNV/ Babesia Quality Control
January 9, 2026 at 6:00 AM
BK251245- Procleix® WNV/ Babesia Quality Control
BK251248- PRiSM PRP
January 9, 2026 at 6:00 AM
BK251248- PRiSM PRP
BK251286- a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems and b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems
January 9, 2026 at 6:00 AM
BK251286- a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems and b) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
January 9, 2026 at 6:00 AM
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
FDA Roundup: January 19, 2024
January 7, 2026 at 6:00 AM
FDA Roundup: January 19, 2024
FDA Roundup: July 14, 2023
January 7, 2026 at 6:00 AM
FDA Roundup: July 14, 2023