What's New at CBER
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- Application History
Updated: 10/27/2016 - 2016 Biological Device Application Approvals
Updated through 9/30/2016; Posted: 10/27/2016 - 2016 Biological License Application Supplement Noteworthy Approvals
Updated through 9/30/2016; Posted: 10/27/2016 - 2016 Biological License Application Approvals
Updated through 9/31/2016; Posted: 10/27/2016 - October 21, 2016 Approval Letter - Reagent Red Blood Cells for use with the IH-System (PDF - 31KB)
Posted 10/27/2016 - October 21, 2016 Approval Letter - Anti-Human Globulin Anti-IgG IH-Card AHG Anti-IgG (PDF - 29KB)
Posted 10/27/2016 - October 21, 2016 Approval Letter - Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing) (PDF - 41KB)
Posted 10/27/2016 - Clinical Investigator Status (Biologics)
Updated through: 10/21/2016; Posted: 10/27/2016 - October 21, 2016 Approval Letter - IH-Cards (STN#: 125094) (PDF - 36KB)
Posted: 10/27/2016 - October 21, 2016 Approval Letter - IH-Anti-D (RH1) Blend (PDF - 41KB)
Posted: 10/27/2016 - October 21, 2016 Approval Letter - IH-Card BGR Products (PDF - 42KB)
Posted: 10/27/2016
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