- Influenza Virus Vaccine for the 2018-2019 Season
Updated: 9/13/2018 - eSubmitter Application History
Updated: 9/13/2018
Recently Added
- Pathogen Reduction Technologies for Blood Safety; Public Workshop
Posted: 9/14/2018 - Influenza Virus Vaccine for the 2018-2019 Season
Updated: 9/13/2018 - eSubmitter Application History
Updated: 9/13/2018 - Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans Draft Agenda
Updated: 9/7/2018 Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB)
Posted: 9/5/2018; Updated through 8/31/2018Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB)
Posted: 9/5/2018; Updated through 8/31/2018Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 737KB)
Posted: 9/5/2018; Updated through 8/31/2018- Complete List of Licensed Products and Establishments
Posted: 9/5/2018; Updated through 8/31/2018 - Exemptions and Alternative Procedures
Updated: 9/4/2018 - CBER-Regulated Products: Current Shortages
Posted: 8/31/2018; Updated manufacturer’s web link to obtain information on Yellow Fever Vaccine. August 29, 2018 Approval Letter - JIVI (PDF - 58KB)
Posted: 8/30/2018- eSubmitter Download and Installation
Updated: 8/30/2018; Link to Download Most Common Issues (August 2018) added - Quantitation of AAV-Based Gene Therapy Products
Posted: 8/29/2018 - CBER Vacancy: Senior Staff Fellow/Visiting Scientist: Allergic Diseases
Posted: 8/29/2018 - BK180231: Trima Accel Automated Blood Collection System
Posted: 8/29/2018 - URGENT Drug Recall for Leukotrap RC System with RC2D Filter
Posted: 8/27/2018 - BK180211: BD BACTEC Platelet Aerobic/F Culture vials; BD BACTEC Platelet Anaerobic/F Culture Vials
Posted: 8/23/2018 - BK180209: SafeTrace Tx 4.0.0
Posted: 8/22/2018 - 2018 Biological Device Application Approvals
Updated: 8/22/2018 - 2018 Biological License Application Approvals
Updated: 8/22/2018 August 1, 2018 Summary Basis for Regulatory Action - PANZYGA (PDF - 276KB)
Posted: 8/21/2018- BK180230: DXT Data Management System, Software Version 3.1
Posted: 8/16/2018 July 27, 2018 Untitled Letter - Registrant of www.testhivstatus.com (PDF - 33KB)
Posted: 8/14/2018July 27, 2018 Untitled Letter - Registrant of www.stdrapidtest.com (PDF - 33KB)
Posted: 8/14/2018
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