This page has been updated recently.
- FY 2016 Report from the Director
Posted: 1/5/2017
Recently Added
FY 2016 Report from the Director
Posted: 1/5/2017- Public Workshop: Emerging Tick-Borne Diseases and Blood Safety
Posted: 1/4/2017 Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry (PDF - 79KB)
Posted: 12/30/2016- Public Workshop: Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products
Posted: 12/29/2016 December 22, 2016 Approval Order - Aptima HIV-1 Quant Assay (PDF - 85KB)
Posted: 12/23/2016December 22, 2016 Approval Letter - ADYNOVATE (PDF - 58KB)
Posted: 12/23/2016- Public Workshop: Pre-Clinical Evaluation of Red Blood Cells for Transfusion
Transcripts posted. Updated: 12/23/2016 December 21, 2016 Approval Letter - Sterile Cord Blood Collection Unit (PDF - 40KB)
Posted: 12/22/2016December 19, 2016 Approval Letter - RabAvert (PDF - 38KB)
Posted: 12/20/2016- CBER-Regulated Products: Resolved Shortages
Updated: 12/20/2016 Statistical Review and Evaluation - FluLaval and FluLaval Quadrivalent (PDF - 150KB)
Posted: 12/15/2016Statistical Review Assay - FluLaval and FluLaval Quadrivalent (PDF - 71KB)
Posted: 12/15/2016Clinical Review - FluLaval and FluLaval Quadrivalent (PDF - 523KB)
Posted: 12/15/2016December 13, 2016 Approval Letter - MACI (PDF - 68KB)
Posted: 12/14/2016Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Guidance for Industry (PDF - 288KB)
Updated: 12/13/2016- Application History
Updated: 12/13/2016 - September 13, 2016 Transcript - Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (PDF - 669KB)
Posted: 12/9/2016 - September 12, 2016 Transcript - Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (PDF - 2.5MB)
Posted: 12/9/2016 - Influenza Virus Vaccine for the 2016-2017 Season
Updated: 12/7/2016 - Summary Basis for Regulatory Action - FluLaval (PDF - 247KB)
Posted: 12/2/2016 - Summary Basis for Regulatory Action - Fluarix and Fluarix Quadrivalent (PDF - 200KB)
Posted: 12/2/2016 - 2016 Biological License Application Approvals
Updated: 11/28/2016 - 2016 Biological License Application Supplement Noteworthy Approvals
Updated: 11/28/2016 - 2016 Biological Device Application Approvals
Updated: 11/28/2016 Dr. PRP America, LLC. - Untitled Letter (PDF - 35KB)
Posted: 11/23/2016
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