Recently Added
- 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 March 15, 2019 - Anti-Fyb (Murine Monoclonal) (Recombinant) (PDF - 42KB)
Posted: 3/19/2019March 15, 2019 Approval Letter - Anti-Fya (Murine Monoclonal) (Recombinant) (PDF - 40KB)
Posted: 3/19/2019- 2019 Biological License Application Approvals
Updated: 3/14/2019; New Entry for ESPEROCT - 2019 Biological Device Application Approvals
Updated 3/14/2019; New Entry for ALBAcyte lgG Sensitized Red Blood Cells II - BK180299 - Arthrex Thrombinator System
Posted: 3/11/2019 - BioCompute Objects: Tools for Communicating NGS Data and Analysis; Public Workshop
Posted: 3/7/2019 Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB)
Posted: 3/4/2019; Updated as of 2/28/2019Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 33KB)
Posted: 3/4/2019; Updated as of 2/28/2019Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 701KB)
Posted: 3/4/2019; Updated as of 2/28/2019- Complete List of Licensed Products and Establishments
Posted: 3/4/2019; Updated as of 2/28/2019 February 28, 2019 Approval Letter - FluMist Quadrivalent (PDF - 33KB)
Posted: 3/1/2019- Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World
Posted: 2/28/2019 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (PDF - 102KB)
Updated: 2/28/2019
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