What’s New for Biologics

What’s New for Biologics

• Exemptions and Alternative Procedures
  Updated: 9/4/2018

Recently Added

• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB) 
  Posted: 9/5/2018; Updated through 8/31/2018
• Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB) 
  Posted: 9/5/2018; Updated through 8/31/2018
• Complete 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.
• Influenza Virus Vaccine for the 2018-2019 Season 
  Posted: 8/30/2018
• 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
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 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
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 8/16/2018
• July 27, 2018 Untitled Letter - Registrant of www.testhivstatus.com (PDF - 33KB) 
  Posted: 8/14/2018
• July 27, 2018 Untitled Letter - Registrant of www.stdrapidtest.com (PDF - 33KB) 
  Posted: 8/14/2018
• Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans Draft Agenda 
  Posted: 8/10/2018
• CBER Key Staff Directory 
  Updated: 8/10/2018
• August 10, 2018 Approval Letter - FluMist (PDF - 102KB) 
  Posted: 8/10/2018
• Influenza Virus Vaccine for the 2018-2019 Season 
  Updated: 8/9/2018
• eSubmitter Application History 
  Updated: 8/7/2018
• July 27, 2018 Untitled Letter - Registrant of www.testkitlabs.com (PDF - 31KB) 
  Posted: 8/7/2018
• July 27, 2018 Untitled Letter - Registrant of www.testkitmart.com (PDF - 32KB) 
  Posted: 8/7/2018
• August 3, 2018 Approval Letter - RabAvert (PDF - 32KB) 
  Posted: 8/7/2018