What’s New for Biologics

What’s New for Biologics

• April 18, 2019 Approval Letter - FLUAD (PDF - 32KB)
  Posted: 4/19/2019
• 2019 Biological License Application Approvals
  Posted: 4/19/2019; Updated as of 3/31/2019
• 2019 Biological Device Application Approvals
  Posted: 4/19/2019; Updated as of 3/31/2019

Recently Added

• April 18, 2019 Approval Letter - Blood Grouping Reagent, Anti-k (Monoclonal) (IgG) (For Further Manufacturing Use) (PDF - 184KB) 
  Posted: 4/19/2019
• April 18, 2019 Approval Letter - Blood Grouping Reagent, Anti-Fyb (Monoclonal) (PDF - 41KB) 
  Posted: 4/19/2019
• April 18, 2019 Approval Letter - Blood Grouping Reagent, Anti-Cw (Monoclonal) (PDF - 41KB) 
  Posted: 4/19/2019
• April 18, 2019 Approval Letter - Blood Grouping Reagent, Anti-k (Monoclonal) (PDF - 44KB) 
  Posted: 4/19/2019
• April 18, 2019 Approval Letter - FLUAD (PDF - 32KB) 
  Posted: 4/19/2019
• 2019 Biological License Application Approvals 
  Posted: 4/19/2019; Updated as of 3/31/2019
• 2019 Biological Device Application Approvals 
  Posted: 4/19/2019; Updated as of 3/31/2019
• Clinical Investigator Status (Biologics) 
  Posted: 4/18/2019; Updated through 3/31/2019
• FDA scientists discover key chemical steps in formation of microparticles carrying abnormal hemoglobin in sickle cell disease 
  Posted: 4/17/2019
• FY 2018 Report from the Director 
  Posted: 4/17/2019
• Important Information for Blood Establishments and Transfusion Services Regarding Acinetobacter sp. Contamination of Platelets for Transfusion 
  Posted: 4/16/2019
• April 15, 2019 Approval Lettter - Flublok Quadrivalent (PDF - 34KB) 
  Posted: 4/16/2019
• March 29, 2019 Approval Letter - Octaplas (PDF - 51KB) 
  Posted: 4/16/2019
• BK180287 - VISTASEAL Dual Applicator 
  Posted: 4/11/2019
• April 9, 2019 Approval Letter - Non-Standardized Allergenic Extracts (PDF - 35KB) 
  Posted: 4/9/2019
• April 5, 2019 Approval Letter - Flucelvax Quadrivalent (PDF - 59KB) 
  Posted: 4/8/2019
• Vaccines and Related Biological Products Advisory Committee - March 22, 2019 Summary Minutes (PDF - 79KB) 
  Posted: 4/5/2019
• April 1, 2019 Approval Letter - ASCENIV (PDF - 78KB) 
  Posted: 4/2/2019
• HCT/P Inspection Information 
  Updated: 4/2/2019
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB) 
  Posted: 4/1/2019; Updated as of 3/31/2019
• Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 33KB) 
  Posted: 4/1/2019; Updated as of 3/31/2019
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 700KB) 
  Posted: 4/1/2019; Updated as of 3/31/2019
• Complete List of Licensed Products and Establishments 
  Posted: 4/1/2019; Updated as of 3/31/2019
• CBER Vacancy: Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602) 
  Posted: 4/1/2019
• March 21, 2019 Approval Letter - IH-Cards (STN#: 125094) (PDF - 32KB) 
  Posted: 3/26/2019
• March 21, 2019 Approval Letter - Anti-Human Globulin Anti-IgG IH-Card AHG Anti-IgG (PDF - 29KB) 
  Posted: 3/26/2019
• March 21, 2019 Approval Letter - Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing) (PDF - 29KB) 
  Posted: 3/26/2019
• March 21, 2019 Approval Letter- IH-Anti-D (RH1) Blend (PDF - 29KB) 
  Posted: 3/26/2019
• March 21, 2019 Approval Letter - IH-Card BGR Products (PDF - 29KB) 
  Posted: 3/26/2019
• March 21, 2019 Approval Letter - Reagent Red Blood Cells for use with the IH-System (PDF - 29KB) 
  Posted: 3/26/2019
• 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