OCTGT Guidance Document Update
description
Transcript of OCTGT Guidance Document Update
OCTGT Guidance Document Update
Rachael Anatol, Ph.D.Associate Director for Policy-New
LegislationFebruary 26, 2014
Outline
• Good Guidance Practices
• Guidance basics
• Guidances issued by OCTGT since 2009
• OCTGT 2014 Guidance Agenda
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
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
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
OCTGT Draft Guidance Documents Published Since Last Update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• Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (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
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
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
OCTGT Contact Information
• Rachael Anatol: [email protected]
• Regulatory Questions: Contact the Regulatory Management Staff in OCTGT at [email protected] or [email protected] or by calling (301) 827-6536
• OCTGT Learn Webinar Series: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm232821.htm
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Public Access to CBERCBER 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: [email protected]
Phone: 301-827-3821
Manufacturers Assistance & Technical Training Branch (MATTB)Email: [email protected]
Phone: 301-827-4081
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