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Last updated 2 days ago
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
2 days ago
Links to the different types of Donor Screening Assays. A table for...
BK251274- RegenBMC® (RegenKit®-THT®-BMC)
2 days ago
The RegenBMC® system is indicated to be used intraoperatively at the point-of-care...
BK261335- LIAISON® MUREX HIV Ab/Ag HT; LIAISON®XL; LIAISON® diluteX
2 days ago
The LIAISON® Murex HIV Ab/Ag HT is an in vitro chemiluminescent immunoassay...
BK261315- ELUclear Elution Kit
2 days ago
The ELUclear Elution Kit removes antibodies bound to red cell antigens through...
MNEXSPIKE
4 days ago
MNEXSPIKE is a vaccine indicated for active immunization to prevent coronavirus disease...
Real-World Evidence
5 days ago
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in...
COMIRNATY
5 days ago
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease...
CBER Labeling Changes Related to Safety Findings that Used Real-World Evidence – FDA and Sponsor Conducted Studies
5 days ago
The Food and Drug Administration (FDA) uses real-world data (RWD) and real-world...
CBER Biological Product Approvals that Used Real-World Evidence
5 days ago
The Food and Drug Administration (FDA) uses real-world data (RWD) and real-world...
CDER Postmarketing Studies that Used Real-World Evidence
5 days ago
The Food and Drug Administration (FDA) uses real-world data (RWD) and real-world...
Blue Horizon International, LLC - 728085 - 05/26/2026
6 days ago
Unapproved New Drugs/Unlicensed Biological Product Violations
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
6 days ago
Guidance for Industry and Review Staff - Drug and Device Manufacturer Communications...