Unofficial FDA What's New: Vaccines, Blood and Biologics Bot
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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
December 23, 2025 at 6:00 AM
Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
Coagulation Factor Xa (Recombinant), Inactivated-ZHZO
December 23, 2025 at 6:00 AM
Coagulation Factor Xa (Recombinant), Inactivated-ZHZO
Coagulation Factors
December 23, 2025 at 6:00 AM
Coagulation Factors
RIASTAP
December 23, 2025 at 6:00 AM
RIASTAP
Plasminogen, Human-tvmh
December 23, 2025 at 6:00 AM
Plasminogen, Human-tvmh
Pooled Plasma (Human), Solvent/Detergent Treated
December 23, 2025 at 6:00 AM
Pooled Plasma (Human), Solvent/Detergent Treated
Prothrombin Complex Concentrate, Human-LANS
December 23, 2025 at 6:00 AM
Prothrombin Complex Concentrate, Human-LANS
Adverse Events and Product Deviation Guidances
December 23, 2025 at 6:00 AM
Adverse Events and Product Deviation Guidances
FDA Roundup: August 25, 2023
December 19, 2025 at 6:00 AM
FDA Roundup: August 25, 2023
Antithrombin III (Human)
December 19, 2025 at 6:00 AM
Antithrombin III (Human)
Antihemophilic Factor (Recombinant)
December 19, 2025 at 6:00 AM
Antihemophilic Factor (Recombinant)
Coagulation Factor VIIa (Recombinant) - JNCW
December 19, 2025 at 6:00 AM
Coagulation Factor VIIa (Recombinant) - JNCW
Processes and Practices Applicable to Bioresearch Monitoring Inspections
December 19, 2025 at 6:00 AM
Processes and Practices Applicable to Bioresearch Monitoring Inspections
FDA Inspections of Clinical Investigators
December 19, 2025 at 6:00 AM
FDA Inspections of Clinical Investigators
FDA Institutional Review Board Inspections
December 19, 2025 at 6:00 AM
FDA Institutional Review Board Inspections
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
December 18, 2025 at 6:00 AM
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Procleix Babesia Assay
December 18, 2025 at 6:00 AM
Procleix Babesia Assay
BK251265 - Ortho Elution Kit
December 18, 2025 at 6:00 AM
BK251265 - Ortho Elution Kit
Cleared 510(k) Submissions with Supporting Documents - 2025
December 18, 2025 at 6:00 AM
Cleared 510(k) Submissions with Supporting Documents - 2025
HIBERIX
December 18, 2025 at 6:00 AM
HIBERIX
Green Valley Fertility Partners - 720249 - 12/03/2025
December 17, 2025 at 6:00 AM
Green Valley Fertility Partners - 720249 - 12/03/2025
Microvascular Tissue, Inc. - 710860 - 12/03/2025
December 17, 2025 at 6:00 AM
Microvascular Tissue, Inc. - 710860 - 12/03/2025
BK251285- Elecsys Syphilis
December 17, 2025 at 6:00 AM
BK251285- Elecsys Syphilis
Fractionated Plasma Products
December 17, 2025 at 6:00 AM
Fractionated Plasma Products
FDA Approves First COVID-19 Vaccine
December 10, 2025 at 6:00 AM
FDA Approves First COVID-19 Vaccine