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OCTGT Guidance Document Update

OCTGT Guidance Document Update. Rachael Anatol, Ph.D. Associate Director for Policy-New Legislation February 26, 2014. Outline. Good Guidance Practices Guidance basics Guidances issued by OCTGT since 2009 OCTGT 2014 Guidance Agenda. Good Guidance Practices (GGPs).

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OCTGT Guidance Document Update

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  1. OCTGT Guidance Document Update Rachael Anatol, Ph.D. Associate Director for Policy-New Legislation February 26, 2014

  2. Outline • Good Guidance Practices • Guidance basics • Guidances issued by OCTGT since 2009 • OCTGT 2014 Guidance Agenda

  3. Good Guidance Practices (GGPs) • FDA’s policies and procedures for developing, issuing, and using guidance documents • Require FDA to publish yearly guidance agenda • Call for public participation

  4. Guidance Document Basics • Documents prepared for FDA, applicants/sponsors, and the public that describe FDA’s interpretation of or policy on a regulatory issue • First means of communication to a broad audience • Not legally binding

  5. Guidance Document Topics • Design, production, labeling, promotion, manufacturing, and testing of regulated products • Processing, content, and evaluation or approval of submissions • Inspection and enforcement policies

  6. OCTGT Draft Guidance Documents Published Since Last Update • Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) ; 2013 • Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponemapallidum(Syphilis) ; 2013 • Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; 2013 • Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System; 2013 • Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System; 2013

  7. OCTGT Final Guidance Documents Published Since Last Update • Preclinical Assessment of Investigational Cellular and Gene Therapy Products; 2013 • Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage; 2011 • Clinical Considerations for Therapeutic Cancer Vaccines; 2011 • Potency Tests for Cellular and Gene Therapy Products; 2011 • Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); 2011 • Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container; 2011 • Cellular Therapy for Cardiac Disease; 2010 • Considerations for Allogeneic Pancreatic Islet Cell Products; 2009

  8. OCTGT Guidances on 2014 CBER Guidance Agenda • Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products • Draft Guidance for Industry: Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue Based Products • Final Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System • Final Guidance for Industry: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

  9. OCTGT Contact Information • Rachael Anatol: Rachael.Strong@fda.hhs.gov • Regulatory Questions: Contact the Regulatory Management Staff in OCTGT at CBEROCTGTRMS@fda.hhs.gov or Lori.Tull@fda.hhs.govor by calling (301) 827-6536 • OCTGT Learn Webinar Series: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm232821.htm

  10. C B E R Public Access to CBER CBER website: http://www.fda.gov/BiologicsBloodVaccines/default.htm. Cellular and gene therapy guidances: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/default.htm Tissue guidances: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/default.htm All biologics guidance and CBER 2014 guidance agenda: http://www.fda.gov/biologicsbloodVaccines/GuidanceComplianceRegulatoryInformation/guidances/default.htm Consumer Affairs Branch (CAB) Email: ocod@fda.hhs.gov Phone: 301-827-3821 Manufacturers Assistance & Technical Training Branch (MATTB) Email: industry.biologics@fda.gov Phone: 301-827-4081 Follow us on Twitter https://www.twitter.com/fdacber

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