What's New for Biologics
What’s New for Biologics
- September 1, 2016 Summary Basis for Regulatory Action - CLEVECORD, HPC Cord Blood (PDF - 217KB)
Posted: 9/26/2016
Recently Added
September 1, 2016 Summary Basis for Regulatory Action - CLEVECORD, HPC Cord Blood (PDF - 217KB)
Posted: 9/26/2016- Medical Officer – Hematology/Oncology
Posted: 9/23/2016 August 31, 2016 Approval Letter - Flucelvax (PDF - 31KB)
Posted: 9/23/2016Final Clinical Review - DAPTACEL (PDF - 414KB)
Posted:9/23/2016Final Clinical Review - Menactra (PDF - 416KB)
Posted: 9/23/2016September 16, 2016 Summary Basis of Regulatory Action - DAPTACEL (PDF - 115KB)
Posted: 9/22/2016September 16, 2016 Summary Basis of Regulatory Action - Menactra (PDF - 222KB)
Posted: 9/22/2016- Influenza Virus Vaccine for the 2016-2017 Season
Updated: 9/21/2016 - Application History
Updated: 9/21/2016 - Public Meeting: Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act
Posted: 9/20/2016 September 16, 2016 Approval Letter - Menactra (PDF - 29KB)
Posted: 9/20/2016September 16, 2016 Approval Letter - DAPTACEL (PDF - 29KB)
Posted: 9/20/2016Statistical-Clinical Review - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (PDF - 395KB)
Posted: 9/20/2016- CBER Vacancy: Cellular Immunotherapy and Cancer Vaccine Review Scientist, GS-13
Posted: 9/16/2016 - 2016 Biological Device Application Approvals
Updated through 8/31/2016; Posted: 9/16/2016 - 2016 Biological License Application Supplement Noteworthy Approvals
Updated through 8/31/2016; Posted: 9/16/2016 Clinical Review - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (PDF - 845KB)
Posted: 9/15/2016Statistical-Clinical Review - Addendum - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (PDF - 92KB)
Posted: 9/15/2016Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry (PDF - 174KB)
Posted: 9/15/2016September 13, 2016 Approval Letter - CUVITRU (PDF - 51KB)
Posted: 9/14/2016The Voice of the Patient: A series of reports from the FDA’s Patient-Focused Drug Development Initiative (PDF - 541KB)
Posted: 9/14/2016September 9, 2016 Summary Basis of Regulatory Action - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (PDF - 119KB)
Posted: 9/13/2016- Application History
Updated: 9/13/2016 September 9, 2016 Approval Letter - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (PDF - 45KB)
Posted: 9/13/2016Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (PDF - 96KB)
This document supersedes the draft guidance of the same title dated December 2015; Posted 9/12/2016- Size and shape of human mesenchymal stem cells may predict future biochemical behavior potentially linked to supporting bone growth
Posted: 9/12/2016 - November 17-18, 2016: Blood Products Advisory Committee Meeting Announcement
Posted: 9/9/2016 - Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products
Updated to include a link to the webcast; Updated: 9/8/2016 Statistical Review - Afluria Quadrivalent (PDF - 251KB)
Posted: 9/6/2016Clinical Review - Afluria Quadrivalent (PDF - 587KB)
Posted: 9/6/2016- Final Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products
Updated: 9/6/2016 September 1, 2016 Approval Letter - Clevecord, HPC Cord Blood (PDF - 62KB)
Posted 9/2/2016August 31, 2016 Summary Basis for Regulatory Action – Prevnar 13 (BL 125324/1371) (PDF - 98KB)
Posted: 9/2/2016August 31, 2016 Summary Basis for Regulatory Action - Prevnar 13 ( BL 125324/1373) (PDF - 84KB)
Posted: 9/2/2016August 31, 2016 Approval Letter - Prevnar 13 (BL 125324/1371) (PDF - 29KB)
Posted: 9/1/2016August 31, 2016 Approval Letter - Prevnar 13 (BL 125324/1373) (PDF - 54KB)
Posted: 9/1/2016August 24, 2016 Summary Basis for Regulatory Action – Afluria Quadrivalent (PDF - 145KB)
Posted: 9/1/2016Studies of morphological "signatures" might improve characterization of mesenchymal stem cells for use in tissue regeneration (PDF - 364KB)
Posted 8/31/2016- Public Workshop: The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) System
Posted: 8/31/2016 - Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval
Updated to include agenda and biographies; Posted: 8/30/2016 August 26, 2016 Approval Letter - AFLURIA QUADRIVALENT (PDF - 42KB)
Posted: 8/26/2016- BK160052: InstaMatch 1.0.0
Posted: 8/26/2016 Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry (PDF - 279KB)
Posted: 8/26/2016Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for FY2015 (PDF - 812KB)
Posted: 8/26/2016- Voluntary Drug Recall Extension - Kogenate FS Antihemophilic Factor (Recombinant)
Posted: 8/22/2016 - Voluntary Drug Recall Extension - Helixate FS
Posted: 8/22/2016 - FDA study of antibody responses to respiratory syncytial virus suggests strategies for developing an effective vaccine against RSV
8/19/2016 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry (PDF - 67KB)
Posted: 8/15/2016- Public Workshop: Pre-Clinical Evaluation of Red Blood Cells for Transfusion
Posted: 8/9/2016
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