What’s New for Biologics

What’s New for Biologics

• 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

Recently Added

• 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
• March 15, 2019 - Anti-Fyb (Murine Monoclonal) (Recombinant) (PDF - 42KB) 
  Posted: 3/19/2019
• March 15, 2019 Approval Letter - Anti-Fya (Murine Monoclonal) (Recombinant) (PDF - 40KB) 
  Posted: 3/19/2019
• 2019 Biological License Application Approvals 
  Updated: 3/14/2019; New Entry for ESPEROCT
• 2019 Biological Device Application Approvals 
  Updated 3/14/2019; New Entry for ALBAcyte lgG Sensitized Red Blood Cells II
• BK180299 - Arthrex Thrombinator System 
  Posted: 3/11/2019
• BioCompute Objects: Tools for Communicating NGS Data and Analysis; Public Workshop 
  Posted: 3/7/2019
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 36KB) 
  Posted: 3/4/2019; Updated as of 2/28/2019
• Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 33KB) 
  Posted: 3/4/2019; Updated as of 2/28/2019
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 701KB) 
  Posted: 3/4/2019; Updated as of 2/28/2019
• Complete List of Licensed Products and Establishments 
  Posted: 3/4/2019; Updated as of 2/28/2019
• February 28, 2019 Approval Letter - FluMist Quadrivalent (PDF - 33KB) 
  Posted: 3/1/2019
• Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World 
  Posted: 2/28/2019
• Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (PDF - 102KB) 
  Updated: 2/28/2019