What’s New for Biologics

What’s New for Biologics

What's New at CBER

• Manufacturers Assistance and Technical Training Branch (MATTB)
  Updated: 6/6/2018

Recently Added

• Manufacturers Assistance and Technical Training Branch (MATTB)
  Updated: 6/6/2018
• May 25, 2018 Summary Basis for Regulatory Action - NGI Ultraqual Multiplex PCR Assay for HCV, HIV-1,HIV-2, and HBV (PDF - 278KB) 
  Posted: 6/5/2017
• May 31, 2018 Approval Letter - BEXSERO (PDF - 97KB) 
  Posted: 6/4/2018
• May 29, 2018 Untitled Letter - Tiger Medical, Inc. (PDF - 324KB) 
  Posted: 6/4/2018
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 84KB) 
  Posted: 6/1/2018; Updated through 5/31/2018
• Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 82KB) 
  Posted: 6/1/2018; Updated through 5/31/2018
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 1.7MB) 
  Posted: 6/1/2018; Updated through 5/31/2018
• Complete List of Licensed Products and Establishments 
  Posted: 6/1/2018; Updated through 5/31/2018
• May 30, 2018 Approval Letter - NGI UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV (PDF - 38KB) 
  Posted: 5/31/2018
• Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (PDF - 100KB) 
  Updated: 5/31/2018
• May 25, 2018 Approval Letter - Procleix West Nile Virus Assay (PDF - 32KB) 
  Posted: 5/30/2018
• CBER-Regulated Products: Current Shortages 
  Updated: 5/24/2018; Hepatitis B Vaccine (Recombinant)
• May 15, 2018 Approval Letter - FluMist Quadrivalent (PDF - 33KB)
  Posted: 5/17/2018
• eSubmitter Application History 
  Updated: 5/16/2018
• May 3, 2018 Summary Basis for Regulatory Action - Procleix Ultrio Elite Assay (PDF - 498KB) 
  Posted: 5/15/2018
• Supporting accurate interpretation of microfluidic system analysis of multipotent stromal cell morphology (PDF - 2.7MB) 
  Posted: 5/14/2018
• CBER-Regulated Products: Current Shortages 
  Posted: 5/14/2018; Zoster Vaccine Recombinant, Adjuvanted
• March 29, 2018 Summary Basis for Regulatory Action - Gammaplex 10% (PDF - 99KB) 
  Posted: 5/11/2018
• BK170150 - Biowy Freezing Bags 
  Posted: 5/11/2018
• BK170144: Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System 
  Posted: 5/11/2018
• CBER-Regulated Products: Resolved Shortages 
  Posted: 5/11/2018; Immune Globulin Intravenous (Human)
• User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act (PDF - 497KB) 
  Posted: 5/10/2018
• April 13, 2018 Summary Basis for Regulatory Action - VONVENDI (PDF - 91KB) 
  Posted: 5/8/2018
• Summary Basis For Regulatory Action - Plasma Cryoprecipitate (for Further Manufacturing Use) (PDF - 84KB) 
  Posted: 5/8/2018
• May 8, 2018: Notification of Stolen Octagam 
  Posted: 5/8/2018
• BK180175 - TANGO infinity Software Version 1.5 
  Posted: 5/8/2018
• BK180174 - IH-Com V5.0 
  Posted: 5/8/2018
• April 13, 2018 Summary Basis for Regulatory Action - KYMRIAH (PDF - 175KB) 
  Posted: 5/7/2018
• May 3, 2018 Approval Letter - Procleix Ultrio Elite Assay (PDF - 42KB) 
  Posted: 5/4/2018
• May 3, 2018 Approval Letter - Plasma Cryoprecipitate (For Further Manufacturing Use) (PDF - 47KB) 
  Posted: 5/4/2018
• May 3, 2018 Approval Letter - ANDEXXA (PDF - 259KB) 
  Posted: 5/4/2018
• BK170132 - Galileo Echo (v.2.0) 
  Posted: 5/3/2018
• BK170135 - Echo Lumena 
  Posted: 5/3/2018
• CBER-Regulated Products: Current Shortages 
  Posted: 5/3/2018; Hepatitis B Vaccine (Recombinant)
• Package Insert - KYMRIAH (PDF - 927KB) 
  Updated: 5/2/2018
• May 1, 2018 Approval Letter - KYMRIAH (PDF - 58KB) 
  Updated: 5/2/2018
• April 27, 2018 Summary Basis for Regulatory Action - Hiberix (PDF - 86KB) 
  Updated: 5/2/2018
• Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry (PDF - 86KB) 
  Updated: 5/2/2018
• April 30, 2018 Approval Letter - Hiberix (PDF - 36KB) 
  Posted: 5/1/2018