INADs and Beginning the Review Process Larisa Rudenko, PhD, DABT.

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

Protocol Deviations : Identification, Responses and Solutions The Office of Human Subjects Research’s Compliance Monitoring Program Educational Seminars:

Assures that feed… –has the identity and strength, which it purports –meets the quality, purity, and safety requirements, which it is represented to possess.

Richard Hibbert RSRL Quality, Assessment and Management Systems Manager Process management Requirements in IAEA Standards and Guides.

The Consent Process: It’s More Than Just a Form A “10 Minute Training” Brought to you by Cyndi Long, MS, RD, CCRC CU Sports Medicine.

Single Use Expanded Access IND/IDE: FDA and IRB Requirements Before and After Use IRB Webinar October 9,2014.

Phenotypic Characterization Harlan Howard, PhD. Describes the animal, construct, and proposed claim Are there sequences that are likely to contain potential.

 Daylene Meuschke, Ed.D Barry Gribbons, Ph.D RP Conference: April 2, 2013.

Pharmacists Responsibilities in Clinical Studies Mike R Sather, PhD Crystal L Harris, PharmD February 26, 2004.

John Naim, PhD Director Clinical Trials Research Unit

CUMC IRB Investigator Meeting Special IND/IDE Considerations: Emergency Use of Investigational Product Compassionate Use & Emergency Research July 21,

Food Safety Assessment Kevin Greenlees, PhD, DABT Kathleen Jones, PhD.

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

CBER Cooperative Manufacturing Arrangements (Contractors) Jennifer Jones Consumer Safety Officer CBER, OBRR, DBA September 15, 2009.

Environmental Safety Assessment Eric Silberhorn, PhD, DABT.

QC/QA Mary Malarkey Director, Division of Case Management Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research March.

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

WHS Management Plans.

Investigational New Drug Application 21 CFR Part 312 A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International

Animal Feed GRAS Notifications Geoffrey K. Wong, M.S. Division of Animal Feeds Center for Veterinary Medicine Pet Food Institute Pet Food Institute October.

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.

Durability Joseph W. (Jay) Cormier, PhD. Describes the animal, construct, and proposed claim Are there sequences that are likely to contain potential.

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.

Regulating Transgenic Animals (Following the Risks) Fred H. Degnan

Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Science CMC Issues for Screening INDs Eric B. Sheinin, Ph.D. Acting Deputy Director.

Regulatory Authority Governing Clinical Trials Anthony J. Minisi, MD Director, Cardiology Fellowship Program.

Responsible Conduct of Research (RCR) Farida Lada October 16, 2013

Carine M. Lenders, M.D., M.S. Medical Director, NFL program Director, Pediatric Nutrition Support Services Research Staff, General Pediatrics Assistant.

Janet Ellen Holwell, CCRC, CCRA President, NY Metropolitan Chapter of ACRP.

Investigational New Drug Application (IND)

Help us Help you: IRB Policy Updates Susan Bankowski, MS, JD IRB Chair.

Clinical Trial Review and Approval: New Regulations and their implications Siddika Mithani, Ph.D Clinical Trials & Special Access Programme Therapeutic.

Regulatory Perspective on Development of

Planned Emergency Research Exception from Informed Consent Requirements September 2007.

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

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

Privacy vs. Confidentiality.  IRB review of privacy and confidentiality protections is required under the Common Rule and the FDA regulations, as well.

Overview of FDA's Regulatory Framework for PET Drugs

Human Subjects Research Office of Responsible Research Practices Human Subjects Research Vanessa Hill, MSHS, CCRC Senior Quality Improvement Specialist.

International Atomic Energy Agency Roles and responsibilities for development of disposal facilities Phil Metcalf Workshop on Strategy and Methodologies.

TUN IRB: The Basics February 26, IRB Function Review human-subject research Ensure the rights & welfare of human subjects are adequately protected.

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

What Institutional Researchers Should Know about the IRB Susan Thompson Senior Research Analyst Office of Institutional Research Presented at the Texas.

Investigational Devices and Humanitarian Use Devices June 2007.

Chief, Gene Therapy Branch

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

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.

21 CFR Toby A. Silverman, M.D. Branch Chief, Clinical Review Branch Division of Hematology, Office of Blood December 14, 2006.

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

NIH Guidelines for Research Involving rDNA Molecules (NIH Guidelines) and Institutional Biosafety Committees.

Regulation of Generic Animal Drugs in the United States

Research ethics.

It’s a food… It’s a drug… It’s AquAdvantage Salmon! Ricardo Carvajal Hyman, Phelps & McNamara, P.C st Annual Tulane.

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

RAC Regulatory Affairs Certification

Regulatory– Terms & Definitions רגולציה - מונחים והגדרות

Premarket Notification 510(k) process

Beverley Alberola, CIP Associate Director, Research Protections

How to Put Together an IDE Application

What is a Data and Safety Monitoring Plan and how do I get one?

Clinical Trial Contracts Office -What’s the Hold Up?

Training Appendix for Adult Protective Services and Employment Supports June 2018.

Human Gene Therapy Institutional Review Procedures

TRTO (Translational Research Trials Office)

Regulatory Perspective of the Use of EHRs in RCTs

Explanation of Science Fair Forms

FDA Regulation of Animal Biotechnology Products

S A Overarching SOPs Funding Secured Training Records

Presentation transcript:

INADs and Beginning the Review Process Larisa Rudenko, PhD, DABT

GE Animal: Investigational Use Outlines obligations and responsibilities Opens path for confidential communications 21 CFR § 511.1b INAD = file; not authorization Allows for certain activities during development Animal (drug) shipments/labeling Record keeping Disposition No investigational animals/products in food/feed supply without prior authorization First look at environmental considerations for animal/product Qualified investigators/collaborators

The NADA/INAD Review Process aka “Ziggy” Hierarchical, weight-of-evidence, risk-based Satisfies statutory requirements for safety, effectiveness Follows NADA regulations, with adaptations for technology/expertise y x

Early Interactions w Sponsor Usually occurs right after opening INAD to ensure confidentiality Sponsor provides some information prior to meeting Generally starts with open seminar, then closed session with review team Discusses nature of submissions; data/information to prepare Follow up includes MOC ? ? ?

In House Review of Submissions Group composition determined by subject area issues, availability Convene Review Group Group Discussion of issues  Suitability, Completeness Assignment of reviews to subject area experts Prepare preliminary review by in-depth reviewers Peer review by group Issue response to Sponsor y x

Our First Approval: GTC’s ATryn ® Producing GE Goats

ATryn Goat Approval (2/6/09) 2 Separate Legal Actions CVM NADA approval rDNA construct in GE goat to produce rh antithrombin in milk CBER BLA approval for ATryn Anticlotting agent for individuals with hereditary clotting disorders in high risk situations

Approval Path

Describes the animal, construct, and proposed claim Product Definition

Broad statement identifying the GE animal, its proposed product or traits (Animal/rDNA construct + claim) Suggested format: An [x-ploid][n-zygous] [animal common name/breed, line] [genus, species] containing [copy number] copy/ies of the [construct name] construct at [genomic location] in the [animal breed/line] that [claim].

GTC Product Definition A specific hemizygous diploid line of domestic goats (Capra aegagrus hircus) containing 5 copies of the Bc6 transgene located at the GTC site directing the expression of the human gene for antithrombin (which is intended for the treatment of humans) in the mammary gland of goats derived from Founder