What’s New for Biologics
Items related to biologics will be added to the top of the list as they are posted on the site.
Recently Added
December 22, 2016 Summary of Safety and Effectiveness - Aptima HIV-1 Quaint assay (PDF - 482KB)
Posted: 1/18/2017Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2017 (PDF - 25KB)
Posted: 1/18/2017Clinical Investigator Status (Biologics)
Updated: 1/13/2017- CBER Vacancy: Medical Officer – Hematology/Oncology
Posted: 1/13/2017 December 9, 2016 Summary Basis for Regulatory Action- Sterile Cord Blood Collection Unit with Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) (PDF - 213KB)
Posted: 1/11/2017December 13, 2016 Summary Basis for Regulatory Action - MACI (PDF - 215KB)
Posted: 1/10/2017Application History
Updated: 1/10/2017Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry (PDF - 99KB)
Updated: 1/9/2017- CBER Vaccine ICSR Implementation - Consolidated Dictionary Business Rules (XLSX - 118KB)
Updated: 1/6/2017 December 22, 2016 Approval Letter - ADYNOVATE (PDF - 52KB)
Updated: 01/06/2017FY 2016 Report from the Director
Posted: 1/5/2017Public Workshop: Emerging Tick-Borne Diseases and Blood Safety
Posted: 1/4/2017Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry (PDF - 79KB)
Posted: 12/30/2016Public Workshop: Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products
Posted: 12/29/2016December 22, 2016 Approval Order - Aptima HIV-1 Quant Assay (PDF - 85KB)
Posted: 12/23/2016Public Workshop: Pre-Clinical Evaluation of Red Blood Cells for Transfusion
Transcripts posted. Updated: 12/23/2016December 21, 2016 Approval Letter - Sterile Cord Blood Collection Unit with Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD) (PDF - 40KB)
Posted: 12/22/2016December 19, 2016 Approval Letter - RabAvert (PDF - 38KB)
Posted: 12/20/2016CBER-Regulated Products: Resolved Shortages
Updated: 12/20/2016Statistical 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: 12/13/2016Application 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