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FDA Update
Scott A. Brubaker, CTBSDirector, Division of Human Tissues
Office of Tissues and Advanced TherapiesCBER/FDA
13th Annual FDA and the Changing Paradigm for HCT/P RegulationFebruary 13, 2017
Alexandria, Virginia
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Outline
• OTAT Update
• Part 15 Hearing
• Public Workshops
• Rule Making
• Guidance Documents(new logo)
www.fda.gov
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• CBER (Center for Biologics Evaluation and Research)
– vaccines, blood products, allergenic products, human tissue/tissue products for transplantation, cells, gene therapy, some devices (related to blood and HCT/Ps)
• CDER (Center for Drug Evaluation and Research)
– drugs, some biological products
• CDRH (Center for Devices and Radiological Health)
– most devices (including for treatment, implants, diagnostics)
FDA Organization
www.fda.gov
www.fda.gov
Effective October 16, 2016
• Name change: Office of Tissues and Advanced Therapies (OTAT)
• All of Office of Cellular, Tissue, and Gene Therapies (OCTGT) is now part of OTAT
• Transfer of some products from Office of Blood Research and Review (OBRR) to OTAT
• Two Divisions in OBRR have transferred to OTAT
– Division of Hematology Clinical Review
– Division of Hematology Research and Review
• Products for transfusion remain in OBRR
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OTAT Products
• Stem cell and stem cell-derived products
– Hematopoietic, mesenchymal, cord blood, embryonic, iPSCs
• Somatic cell therapies
– Pancreatic islets, chondrocytes, myoblasts, keratinocytes, hepatocytes
• Therapeutic vaccines and other antigen-specific active immunotherapies
– Cancer vaccines and immunotherapies, such as dendritic cells, lymphocyte-based therapies, cancer cell-based therapies, peptides, proteins
– Non-infectious disease therapeutic vaccines, such as peptides, proteins, small molecules
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OTAT Products, Cont’d.
• Gene therapies
– Genetically modified cells
– Plasmids, viral vectors, bacterial vectors
• Purified and recombinant proteins for hematology (e.g., coagulation factors, thrombin, botulism antitoxin, diphtheria anti-toxin, fibrin sealants)
• Antivenins
• Some devices and combination products
– Devices with a cellular component
– Selection devices for the manufacture or delivery of cells
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Office of Tissues and Advanced Therapies (OTAT)
www.fda.gov
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Part 15 Public Hearing
• Request for Comments - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products (9-12-16 & 9-13-16)
– Convened two-day event with over 90 presenters representing industry, patient advocacy, academia, and individuals; 400 attended in person or by webcast
– Obtained stakeholder input on draft guidance regarding regulation of human cell and tissue-based products: minimal manipulation; homologous use; same surgical procedure exception; and HCT/Ps from adipose tissue
– FDA is currently considering comments
www.fda.gov
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CBER Public Workshops
• Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval (9-8-16)
– Discussed scientific considerations and challenges in development of human cells, tissues, and cellular and tissue-based products (HCT/Ps) subject to premarket approval, including stem cell-based products
www.fda.gov
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CBER Public Workshops, Cont’d.
• Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products (2-8-17 & 2-9-17)
– The purpose of the public workshop was to have a scientific discussion of the current methods available for identifying and characterizing infectious disease risks associated with human cells, tissues, and cellular and tissue-based products (HCT/Ps).
www.fda.gov
RULE MAKING
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Final Rules
• Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule, June 22, 2016
• Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Final Rule, August 31, 2016
www.fda.gov
GUIDANCE DOCUMENTS
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Guidance Documents
• Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry, March 2016
• Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271, March 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, August 2016
www.fda.gov
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Guidance Documents, Cont’d.
• Use 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, September 2016
• Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry, November 2016
www.fda.gov
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OTAT Contact Information
Scott A. Brubaker, CTBS
Regulatory Questions
Contact the Regulatory Management Staff at:
240-402-8190
OTAT Learn Webinar Series http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm232821.htm
www.fda.gov
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Public Access to CBER
www.fda.gov
CBER websitehttp://www.fda.gov/BiologicsBloodVaccines/default.htm
1-800-835-4709 or 240-402-8010
Consumer Affairs Branch (CAB) [email protected]
240-402-8010
Manufacturers Assistance and Technical Training Branch (MATTB)[email protected]
240-402-8010
Follow us on Twitter https://www.twitter.com/fdacber
