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Recently Added
April 18, 2019 Approval Letter - FLUAD (PDF - 32KB)
Posted: 4/19/2019- 2019 Biological License Application Approvals
Posted: 4/19/2019; Updated as of 3/31/2019 - 2019 Biological Device Application Approvals
Posted: 4/19/2019; Updated as of 3/31/2019 - Clinical Investigator Status (Biologics)
Posted: 4/18/2019; Updated through 3/31/2019 - FDA scientists discover key chemical steps in formation of microparticles carrying abnormal hemoglobin in sickle cell disease
Posted: 4/17/2019 - FY 2018 Report from the Director
Posted: 4/17/2019 - Important Information for Blood Establishments and Transfusion Services Regarding Acinetobacter sp. Contamination of Platelets for Transfusion
Posted: 4/16/2019 April 15, 2019 Approval Lettter - Flublok Quadrivalent (PDF - 34KB)
Posted: 4/16/2019March 29, 2019 Approval Letter - Octaplas (PDF - 51KB)
Posted: 4/16/2019- BK180287 - VISTASEAL Dual Applicator
Posted: 4/11/2019 April 9, 2019 Approval Letter - Non-Standardized Allergenic Extracts (PDF - 35KB)
Posted: 4/9/2019April 5, 2019 Approval Letter - Flucelvax Quadrivalent (PDF - 59KB)
Posted: 4/8/2019Vaccines and Related Biological Products Advisory Committee - March 22, 2019 Summary Minutes (PDF - 79KB)
Posted: 4/5/2019April 1, 2019 Approval Letter - ASCENIV (PDF - 78KB)
Posted: 4/2/2019- HCT/P Inspection Information
Updated: 4/2/2019 Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB)
Posted: 4/1/2019; Updated as of 3/31/2019Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 33KB)
Posted: 4/1/2019; Updated as of 3/31/2019Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 700KB)
Posted: 4/1/2019; Updated as of 3/31/2019- Complete List of Licensed Products and Establishments
Posted: 4/1/2019; Updated as of 3/31/2019 - CBER Vacancy: Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602)
Posted: 4/1/2019 March 21, 2019 Approval Letter - IH-Cards (STN#: 125094) (PDF - 32KB)
Posted: 3/26/2019March 21, 2019 Approval Letter - Anti-Human Globulin Anti-IgG IH-Card AHG Anti-IgG (PDF - 29KB)
Posted: 3/26/2019March 21, 2019 Approval Letter - Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing) (PDF - 29KB)
Posted: 3/26/2019March 21, 2019 Approval Letter- IH-Anti-D (RH1) Blend (PDF - 29KB)
Posted: 3/26/2019March 21, 2019 Approval Letter - IH-Card BGR Products (PDF - 29KB)
Posted: 3/26/2019March 21, 2019 Approval Letter - Reagent Red Blood Cells for use with the IH-System (PDF - 29KB)
Posted: 3/26/2019- BK180275 - IH-Com V5.0
Posted: 3/26/2019 - BK180274 - IH-500 Analyzer
Posted: 3/26/2019 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry (PDF - 133KB)
Posted: 3/25/2019- eSubmitter Application History
Updated: 3/20/2019
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