FDA Regulation of Animal Biotechnology Products

Slides:

Advertisements

Similar presentations

Inadequacies in the Federal Regulation of Agricultural Biotechnology Gregory Jaffe Director, Biotechnology Project Center for Science in the Public Interest.

Advertisements

Foundations of Regulation

Regulatory Clinical Trials Clinical Trials. Clinical Trials Definition: research studies to find ways to improve health Definition: research studies to.

"Determining the Regulatory Pathway to Market" Classification Heather S. Rosecrans Director, 510(k) Staff Office of Device Evaluation Center for Devices.

Steven D. Vaughn, DVM Director Office of New Animal Drug Evaluation Center for Veterinary Medicine U. S. Food and Drug Administration June 6, 2012 Embracing.

Humanitarian Device Exemptions (HDE) 101 Elizabeth Hillebrenner, MSE Biomedical Engineer IDE and HDE Program Staff Center for Devices and Radiological.

Strengthening the Medical Device Clinical Trial Enterprise

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

Integrating CMC Review & Inspection Industry Recommendations Joe Anisko April 24, 2003.

Introduction to Regulation

Proposed Rules under the FDA Food Safety Modernization Act

Effectiveness Evaluation for Therapeutic Drugs for Non-Food Animals

Jeff Jones, DVM, PhD Animal Biotechnology Interdisciplinary Group Center for Veterinary Medicine U.S. Food and Drug Administration Regulation of Genetically.

FDA’s Policy for Evaluating Bioengineered Foods Jeanette Glover Glew Food and Drug Administration Center For Food Safety and Applied Nutrition September,

Background, Introduction, Statutory Authority, Introduction to Risk-Based Approach Larisa Rudenko, PhD, DABT.

The FDA Landscape AdvaMed September 2008 Judith K. Meritz

+ Medical Devices Approval Process. + Objectives Define a medical device Be familiar with the classification system for medical devices Understand the.

Malini M. Wileman, PhD, RAC Animal Biotechnology Interdisciplinary Group Center for Veterinary Medicine U.S. Food and Drug Administration Regulation of.

Mrs. Brandi Robinson Office of New Animal Drug Evaluation Center for Veterinary Medicine Regulating Animal Drugs.

1 The FDA and Animal Drug Compounding Neal Bataller, DVM FDA/Center for Veterinary Medicine AAVPT 14 th Biennial Symposium, May 16-17, 2005, Rockville,

1 ACPS November 15, Update Nancy B. Sager, Associate Director Office of Pharmaceutical Science Center for Drug Evaluation & Research Food and.

FDA Recalls Risk Communication Advisory Committee David K. Elder Director, Office of Enforcement.

Center for Veterinary Medicine (CVM) RECALLS.  21 CFR 7.40 provides guidance on the policy, procedures, and industry responsibilities for recalls. 

Stakeholders In Clinical Research Government and Regulatory Bodies Professor Phil Warner.

Industry Perspective on Challenges for Product Developers - Drugs Christine Allison, M.S., RAC Associate Regulatory Consultant, Global Regulatory Affairs.

Modernization of Health Canada Food Frameworks Foundations for Change Presentation to the Canadian Health Food Association June

FDA’s Draft LDT Framework & Personalized Medicine Update

Main Requirements on Different Stages of the Licensing Process for New Nuclear Facilities Module 4.1 Steps in the Licensing Process Geoff Vaughan University.

1 Combination Products: Jurisdictional Issues MassMEDIC Presentation March 28, 2006 Janice Hogan, Esq. Partner Hogan & Hartson, LLP

Preventive Controls for Human Food S upplemental Proposal 1

IAEA International Atomic Energy Agency School of Drafting Regulations – November 2014 Government and Regulatory Body Functions and Responsibilities IAEA.

Environmental Assessment of Genetically Engineered Animals at CVM (FDA) Animal Biotechnology Interdisciplinary Group Center for Veterinary Medicine U.S.

Progress in FDA’s Drug Product Quality Initiative Janet Woodcock, M.D. November 13, 2003.

Enforcement Litigation and Compliance Washington, DC December 9-10, 2015 Compliance Central with FDA Center Compliance Directors (Part I) Michael Roosevelt,

Overview FDA Food Safety Modernization Act Section 104

EPA P-1 Corrective Action Streamlined Consent Orders Bob Greaves Region 3 Deb Goldblum Region 3 Tom Krueger Region 5.

Environmental Assessment of Genetically Engineered Animals at CVM (FDA) Animal Biotechnology Interdisciplinary Group Center for Veterinary Medicine U.S.

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.

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

1 VICH AND VETERINARY MEDICINES AVAILABILITY VICH5 CONFERENCE, OCTOBER 2015, TOKYO VICH AND VETERINARY MEDICINES AVAILABILITY VICH5 CONFERENCE, OCTOBER.

The Benefits of VICH to VICH Member Countries and Regions DONALD A. PRATER, DVM Director, U.S. FDA Europe Office Office of International Programs Office.

Regulation of Generic Animal Drugs in the United States

Import Safety Phase 2 Workgroup 1.

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

FDA DRUG APPROVAL FDA’s Lengthy Drug Approval Process in Twelve Steps Overview of the FDA Drug Approval Process Drug Developed June 13, 2016 | Emilia Varrone.

Center for Food Safety & Applied Nutrition: Update

Regulatory Updates Health Sciences Authority Singapore

Strengthening the Medical Device Clinical Trial Enterprise

Jeff Shuren, MD, JD Center for Devices and Radiological Health U. S

Grade A Dairy Equivalence

U.S. FDA Center for Devices and Radiological Health Update

Regulatory– Terms & Definitions רגולציה - מונחים והגדרות

Premarket Notification 510(k) process

FDA’s IDE Decisions and Communications

How to Put Together an IDE Application

Balancing Pre and Postmarket Requirements Different Scenarios

Balancing Regulation and Innovation: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

The FDA Early Feasibility Study Pilot and the Innovation Pathway

FDA Guidance for Industry and FDA Staff Summary of Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) Effective: December.

Introduction of New Technology: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Medical Device Regulatory Essentials: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

Updated FDA Food Facility Registration Overview

FDA-CDRH in the Next Decade A Vision for Change

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.

FDA Resources and Meetings

US REGULATORY UPDATE: IMPACT OF FSMA & VFD ON THE AQUACULTURE INDUSTRY

Linda M. Chatwin, Esq. RAC Business Manager, UL LLC

What Is VQIP? FDA required to establish a program to provide for the expedited review of food imported by voluntary participants. Eligibility is limited.

Stakeholder Engagement: Webinar Part I: The Regulatory Development Process for the Government of Canada Part II: Making Technical Regulations Under.

Compounded Drugs and Lack of Premarket FDA-Approval

Presentation transcript:

FDA Regulation of Animal Biotechnology Products Laura Epstein Center for Veterinary Medicine U.S. Food and Drug Administration July 23, 2019

Legal Authority FD&C Act: a drug = articles (other than food) intended to affect the structure or any function of the body of man or other animals... Generally, must be approved www.fda.gov

How Can an Animal be a Drug? Answer: The animal is not a drug The regulated article is the intentional genomic alteration (IGA) FDA does not approve the animal www.fda.gov

What This Really Means FDA ensures it’s: Safe to the animal Safe to anyone that consumes food from the animal Effective (does what it’s supposed to do) www.fda.gov

Section 4, Regulatory Streamlining EO on Modernizing Regulatory Framework for Agricultural Biotechnology Products Section 4, Regulatory Streamlining Section 4(a): “within 180 days… identify relevant regulations and guidance documents… that can be streamlined…” Section 4(b): “use existing statutory authority, as appropriate, to exempt low-risk products of agricultural biotechnology from undue regulation”

Response to EO, Section 4: Guidance 187 on Regulation of IGAs in Animals Draft revision issued in 2017 IGAs require premarket approval but enforcement discretion for low risk IGAs in animals Explains how approval process works Changes will clarify risk-based approach; eliminate confusing jargon; respond to commenters’ concerns FDA plans an outreach effort to engage stakeholders in a more technical revision of portion of guidance on the approval process; goal will be further streamlining

GFI 187: Risk-Based Approach Enforcement Discretion with no prior data review No data submission Data to address relevant risk factors Data commensurate with the risk profile of the product Enforcement Discretion with prior data review New Animal Drug Application (NADA) Approval www.fda.gov

GFI 187: Clarification for Farms/Animal Producers Farms that are just raising animals containing IGAs: Are not drug manufacturing facilities Do not have to register with FDA Are not required to report adverse events to FDA (although they can voluntarily) Do not need FDA approval to breed animals with IGAs with other animals

Response to EO, Section 4: Other Guidances Guidance on IGAs in animals of food-producing species for use as models of human disease in research: Intend not to enforce approval requirement for a low-risk product Guidance on establishing files of early information: will streamline regulation at early development stage by allowing use of a type of file that allows communication with FDA without incurring user fees

Response to EO, Section 4: Veterinary Innovation Program (VIP) Available to IGAs in animals and ACTPs seeking approval that provide a benefit to health, food production, animal well-being Furthers EO goals of timely and efficient application review and predictability and consistency of regulation Currently 11 sponsors enrolled more expected to enroll shortly

VIP, continued Benefits: VIP Toolkit Frequent Interaction: meetings early and often Dedicated Review Team Alternative Data Discussions CVM Senior Management Involvement Feedback on Assay Development Pre- and Post-Review Feedback Stopping/Re-starting the clock “How-to” help with Post approval requirements

Response to EO Section 4: Transparency in Risk Determination Following EO issuance, CVM created a web page that lists the IGAs in animals for which it has made a risk-based decision to exercise enforcement discretion rather than enforcing approval requirements