What’s New for Biologics

What’s New for Biologics

Recently Added

• Product Application Notice: Acrodose PLus Systems 
  Posted: 4/13/2018
• eSubmitter Application History 
  Posted: 4/10/2018
• Clinical Investigator Status (Biologics) 
  Posted: 4/10/2018; Updated through 3/31/2018
• BK180185: PCS 300 Plasma Collection System 
  Posted: 4/9/2018
• Urgent Medical Device Recall For Acrodose PLus and PL Systems
  Posted: 4/6/2018
• Urgent: 4R5725 and 6R5725 Recall/Field Action 
  Posted: 4/6/2018
• April 4, 2018 Approval Letter - Flublok Quadrivalent (PDF - 32KB) 
  Posted: 4/6/2018
• Fast Track Designation Request Performance 
  Posted: 4/6/2018
• Urgent: Recall Notification Prothrombin Complex Concentrate (Human) 
  Posted: 4/5/2018
• CBER Vacancy: Medical Officer (Hematology/Oncology) 
  Posted: 4/2/2018
• March 6, 2018 Summary Basis for Regulatory Action - Babesia microti NAT/Babesia microti NAT for Blood Screening (PDF - 199KB) 
  Posted: 3/29/2018
• CBER Vacancy: Director, Office of Blood Research and Review (OBRR) 
  Posted: 3/28/2018
• User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act 
  Posted: 3/28/2018
• Zostavax (Herpes Zoster Vaccine) Questions and Answers 
  Updated: 3/28/2018
• 2018 Center for Biologics Evaluation and Research Science Symposium 
  Posted: 3/27/18
• March 22, 2018 Approval Letter - HEPLISAV-B (PDF - 43KB) 
  Posted: 3/23/2018
• March 16, 2018 Approval Letter - Fluarix Quadrivalent (PDF - 94KB) 
  Posted: 3/22/2018
• March 21, 2018 Approval Letter - Zostavax (PDF - 93KB) 
  Posted: 3/22/2018
• Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2018 (PDF - 43KB) 
  Updated: 3/21/2018
• Summary of Safety and Effectiveness - Elecsys HIV combi PT (BP160050.5) (PDF - 663KB) 
  Posted: 3/21/2018
• March 21-22, 2018 Blood Products Advisory Committee (BPAC) Inclement Weather Advisory Guidance 
  Posted: 3/20/2018
• March 6, 2018 Summary Basis for Regulatory Action -Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening (PDF - 206KB) 
  Posted: 3/20/2018
• March 14, 2018 Approval Order - Elecsys HIV combi PT (PDF - 195KB) 
  Posted: 3/20/2018
• March 14, 2018 Summary Basis for Regulatory Action - Hizentra (PDF - 257KB) 
  Posted: 3/20/2018
• March 15, 2018 Approval Letter - Hizentra (PDF - 120KB) 
  Posted: 3/15/2018
• March 14, 2018 Approval Letter - Trumenba (PDF - 96KB) 
  Posted: 3/15/2018