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

Slides:

Advertisements

Similar presentations

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDAs website for reference purposes only. It.

Advertisements

Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob.

Regulatory Challenges in the Cell Preparation Facility Adrian Gee Center for Cell & Gene Therapy Regulatory Challenges in the Cell Preparation Facility.

CBER U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development IND Case Studies.

Development of Guidance Documents Jennifer Scharpf, M. P. H

Reagents Used in Cell Therapy Manufacturing

Mitochondrial Manipulation Technologies: Preclinical Considerations

FDA Update on Laboratory Developed Tests Oversight Laura M. St. Martin, M.D., M.P.H. Acting Branch Chief, Human Tissues and Reproduction Branch, Division.

1 CBER Rare Diseases Program - Update Nisha Jain, MD Chief, Clinical Review Branch DH/OBRR/CBER/FDA May 15, 2012 NORD Corporate Council.

FDA Oversight of Cell Therapy Clinical Trials

Introduction to Regulation

Center for Biologics Evaluation and Research Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products Carolyn.

Center for Biologics Evaluation and Research FDA Overview Site Visit Carolyn A. Wilson, Ph.D. Associate Director for Research.

1 Overview: Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies Raj K. Puri, M.D., Ph.D. Director, DCGT Office of Cellular,

FDA Basics: Tissue Safety

Samuel B. Barone, MD Division of Human Tissues

1 FDA Draft Guidance: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapies John Hyde, PhD, MD OCTGT / CBER Cellular,

1 FDA Regulation of Cellular, Tissue, and Gene Therapies Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies, FDA Phacilitate.

Cellular Tissue and Gene Therapies Research Site Visit Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies September 29,

Fecal Microbiota for Transplantation

Food and Drug Administration Center for Biologics Evaluation and Research The Office of Cellular, Tissue and Gene Therapies Web Seminar Series presents:

CBER U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Cellular Therapy Products

1 First-in-Human Trials of Cellular Therapies John Hyde, Ph.D., M.D. Office of Cellular, Tissue, and Gene Therapies Division of Clinical Evaluation and.

Ensuring Product Quality in Gene Transfer Clinical Trials

Cellular Products for Cardiac Diseases Dwaine Rieves, MD Center for Biologics Evaluation and Research FDA Perspective on:

CBER Review Considerations on Source Plasma Vaccination Programs Judy Ellen Ciaraldi BS, MT(ASCP)SBB, CQA(ASQ) CBER, OBRR, DBA September 16, 2009.

Regulation of Blood & Blood Products and Cell, Tissue & Gene Therapies Elizabeth Read, MD Epi 260 UCSF May 9, 2012.

INTRODUCTION TO RA.

Associate Director for Research, OCTGT

1 FDA Regulation of Cell Therapy Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies Fourth Annual Translational Stem.

OCTGT Overview Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies CTGTAC Meeting July 26, 2007.

Animal Models for Porcine Xenotransplantation Products Intended to Treat Type 1 Diabetes or Acute Liver Failure CTGTAC #47 May 14, 2009.

Division of Hematology Basil Golding M.D. Division Director Site Visits 2010 Laboratories of Hemostasis, and Plasma Derivatives.

Approval Criteria for Assays for Testing Blood Donors for West Nile Virus Robin Biswas, M.D. CBER, FDA Blood Products Advisory Committee Meeting March.

UNCLASSIFIED10/12/ :41 AM Slide 1 Division of Regulated Activities and Compliance.

CBER HCT/P Contamination Prevention and Biologic Product Sterility Regulations Applicable to PBSCs Cell Therapy Liaison Meeting June 16, 2006 Ellen F.

FDA’s Draft LDT Framework & Personalized Medicine Update

Humanitarian Use Devices September 23, 2011 Theodore Stevens, MS, RAC Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and.

1 U.S. vCJD Donor Screening: Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps) Melissa A Greenwald, MD CAPT, U.S. Public Health Service.

1 Safety of Cell Therapies Derived from Human Embryonic Stem Cells CTGTAC #45 April 10, 2008.

Review of Site Visit Report Laboratory of Molecular Virology DETTD/OBRR/CBER March 18, 2005 Hira L. Nakhasi, Ph.D. Director, DETTD.

Welcome and Introduction Lee S. Simon, MD Division Director Analgesic, Anti-inflammatory and Ophthalmologic Drug Products ODEV/CDER.

The FDA: Basic Facts It takes 12 to 15 years to develop a single drug Only 1 in 10,000 potential medications makes it completely through the process Only.

DEPARTMENT OF HEALTH CENTER FOR BIOLOGICS AND HUMAN SERVICESEVALUATION and RESEARCH AND HUMAN SERVICES EVALUATION and RESEARCH Update on OCTGT Guidance.

Utah Life Science Summit Nov Phil Triolo, PhD RAC President, Phil Triolo and Associates LC.

FDA’s Role in Facilitating the Availability of Influenza Vaccine Norman W. Baylor, Ph.D. Director, Office of Vaccines Research and Review CBER/FDA.

Chief, Gene Therapy Branch

Minimizing the Risks of TSE Agents in Human Tissues Melissa A. Greenwald, M.D. Division of Human Tissues Office of Cellular, Tissue and Gene Therapies;

Research in the Office of Vaccines Research and Review: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation and Research.

Research in the Office of Cellular, Tissue and Gene Therapies: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation.

Food and Drug Administration Center for Biologics Evaluation and Research The Office of Cellular, Tissue, and Gene Therapies Web Seminar Series presents:

Comments of International Society for Cellular Therapy (ISCT) to FDA Cellular, Tissue, & Gene Therapies Advisory Committee Elizabeth Read, MD March 30,

Human Specimen Repositories Requirements of 21 CFR Parts 50 & 56 PRIM & R May 5, 2004 Sally A. Hojvat, Ph.D. Director of Microbiology Devices Office of.

Center for Biologics Evaluation and Research, FDA Site Visit Introduction Kathryn M. Carbone, M.D. Associate Director for Research.

Functional Vision Endpoints: OCTGT Perspective Samuel B. Barone, M.D. Office of Cellular, Tissue, and Gene Therapies Center for Biologics Evaluation and.

DEPARTMENT OF HEALTH CENTER FOR BIOLOGICS AND HUMAN SERVICESEVALUATION and RESEARCH AND HUMAN SERVICES EVALUATION and RESEARCH Update on OCTGT Guidance.

CBER FDA Science Board Office of Cellular, Tissue, and Gene Therapies (OCTGT) Kathryn C. Zoon, PhD October 25, 2002.

Creating Connections. Saving Lives. ™ NATIONAL MARROW DONOR PROGRAM ® Regulation of PBSC and DLI from Unrelated Donors: Meeting the Needs of the U.S. Public.

West Nile Virus (WNV) and Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Melissa A. Greenwald, MD Division of Human Tissues.

FDA’s vCJD Risk Communication on US Plasma- Derived Factor VIII and UK Plasma-Derived Factor XI BPAC April 27, 2007 Mark Weinstein, Ph.D. FDA, Center for.

DEPARTMENT OF HEALTH CENTER FOR BIOLOGICS AND HUMAN SERVICESEVALUATION and RESEARCH AND HUMAN SERVICES EVALUATION and RESEARCH Update on the Somatic Cell.

Guidance Development Merton V. Smith, Ph.D., J.D. Director International Programs and Product Standards Center for Veterinary Medicine, FDA.

Introduction Review and proper registration of Human Gene Transfer protocols is very complex. A protocol goes through rigorous review by multiple Committees.

Donald W. Fink, Jr., Ph.D. Division of Cellular and Gene Therapies

Guidance for review of studies involving HCT/Ps and IND Basics

Clinical Investigator Training Course

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Human Gene Therapy Institutional Review Procedures

Presentation transcript:

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) 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: Regulatory Questions: Contact the Regulatory Management Staff in OCTGT at or or by calling (301) OCTGT Learn Webinar Series: ucm htm ucm htm 9

Public Access to CBER CBER website: Cellular and gene therapy guidances: ult.htm Tissue guidances: All biologics guidance and CBER 2014 guidance agenda: Consumer Affairs Branch (CAB) Phone: Manufacturers Assistance & Technical Training Branch (MATTB) Phone: Follow us on Twitter