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The Veterinary Drug Approval Process and FDA Regulatory Oversight  

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Seminar Summary:

This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDAs veterinary drug approval process (see full course description)

 

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Training Course Syllabus:


The Veterinary Drug Approval Process and FDA Regulatory Oversight: 2-day In-Person Seminar

Course Description:

The U.S. Food and Drug Administrations Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agricultures Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency.

This seminar on veterinary medicine regulations will provide attendees with an understanding of FDAs veterinary drug approval process. This two day interactive course will cover:

Premarket approval process
Various sections of a New Animal Drug Application
Strategies for navigating the FDA approval process and for expending product approval
The nature of shared jurisdiction over veterinary products in certain cases.


Learning Objectives:

Upon completing this course on veterinary medicine regulations participants will:

  • Understand how the U.S. Food and Drug Administration regulates veterinary drug product.
  • Understand how FDAs Center for Veterinary Medicine is organized.
  • Discuss the process by which veterinary drug products are reviewed and approved.
  • Learn how to open an INAD File and request fee waivers.
  • Obtain a working knowledge of various sections included within an NADA.
  • Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness.
  • Analyze FDAs rules governing chemistry, manufacturing and controls or CMC.
  • Understand the various components of an animal field study to support product approval.
  • Discuss the difference between FDAs various user fees and fee waivers.
  • Identify the elements of an FDA compliant label.
  • Develop a corporate compliance strategy covering labeling, marketing and advertising.
  • Problem solving methods to mitigate regulatory enforcement risks.
  • Explain how jurisdiction is split between various Federal agencies in a certain cases.
  • Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S.
Course Outline:
Day One (8:30 AM 4:30 PM)

Registration Process: 8:30 AM 9:00 AM

Session Start Time: 9:00 AM

Introduction to the FDA Veterinary Drug Approval Process

Introduction to the FDA, CVM, and the FDCA
Role and Function of FDA Generally
FDAs purpose and mission
FDAs jurisdiction
FDAs six product centers
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Tobacco Products
Center for Veterinary Medicine (CVM)
FDAs operation
Structure of FDA: Specifics of CVM
CVMs Mission
CVMs Jurisdiction
CVMs Organization (discuss divisions and duties within each office)
Intro to the FDCA, Regulations, and guidance
Overview of FDCA and regulations
Introduction to FDA guidance
Overview of Veterinary Drug Approval Process
Start to Finish Overview
Research and Development Phase
Pilot/Bench Studies
Pre-INADA Meeting
Open INAD File
NADA (8 sections)
5 Major Technical Sections
Chemistry, Manufacturing and Controls (CMC)
Safety (target animal safety study)
Efficacy (field study)
Human Food Safety (human food safety studies for food-producing animals)
Environmental Impact (EA/CE)
3 Minor Technical Sections
All other information
Labeling
Freedom of Information Summary
FDA decision on approval
Notice of approval in Federal Register
Preliminary Patent Protection Concerns
Timing Considerations: File for Patent before Filing for Market Approval
Scope of Patent Filing: Encompass All Variants in One or Multiple Patents
Types of Filing: Domestic and International Patent Cooperation Treaty
Approval Process: Safety, Effectiveness, and Human Food Safety
Safety
Content and format
Final Study Reports
Monitoring and Reporting Adverse Drug Events
Effectiveness
Dosage Characterization
Substantial evidence (e.g. dose confirmation and clinical field studies)
All other information related to effectiveness
Proposed effectiveness-related labeling
Effectiveness section of the FOI summary of safety and effectiveness studies
Effectiveness Guidance Documents
Human Food Safety
Analysis of Drug Residues
Toxicology
Residue Chemistry
Microbial Food Safety
Regulatory Method Relied Upon by Sponsor
New Animal Drugs with Cancer-Causing Potential
Background on regulation
Sensitivity-of-Method Procedures


Day Two (8:30 AM 4:30 PM)


Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials
NADA CMC Component Sections
General Information
Nomenclature, Structure, and General Properties
Manufacture
The manufacturing process and control process
Materials used: i.e., starting materials, reagents, solvents, diluents, etc.
Identification of operating parameters, environmental controls, and intermediary controls
Validating the manufacturing processes
Drug Substance Characterization
Data and Analysis supporting structure information on impurities
Control of Drug Substance
Proposed specification for drug substance
Analytical procedures used in testing drug substances
Validation of analytical procedures
Description of relevant batches and results of batch analyses
Reference Standards
Information on reference standards or reference materials used for testing
Container Closure System
Indication of material used to construct each primary and secondary packaging component
Suitability of the container closure system
Stability of container closure system
Stability
Summary of Types of Studies Conducted, protocols used, and results of studies
Detailed explanation of results of stability study in tabular, graphical, or narrative format
Environmental Impact
Categorical Exclusions
Environmental Assessments (EA)
Common EA Components
Environmental Impact Statements (EIS)
Managing Veterinary Clinical Trials
The 7 Major Phases of Animal Field Studies
Planning
Study Initiation
In-life Activities
Site close-out
Data management
Biostatistical analysis
Report writing
Animal Drug User Fees and Related Fee Waivers
Veterinary Drug User Fees and Fee Reductions and Waivers
Animal Drug User Fee Act (ADUFA) Applies to Innovators Only
Animal Generic Drug User Fee Act (ADGUF) Applies to Generic Manufacturers
Types of User Fees
Animal Drug Application and Supplement Fee
Animal Drug Product Fee
Animal Establishment Fee
Animal Drug Sponsor FEE
Types of Fee Waivers and Reductions
Significant Barrier to Innovation
Fees Exceed Costs
Free-Choice Feeds
Minor Use or Minor Species
Small Business
Procedures, Timing and FDA Evaluation of Waivers or Reductions
Introduction to FDAs Regulation of Veterinary Feed, OTC Drugs and Supplements
Animal Feed
The concept of GRAS
Feed Labeling
AAFCO and its Relationship with FDA
Veterinary OTC Drugs and Nutritional Supplements
Regulatory Agencies: FDA & FTC
Standards to Avoid Misbranding and FTC Violation: Must not be False and Misleading
CVM Draft Compliance Policy - CPG 690.150 & FDA CPG 690.100
Factors Influencing Initiation of FDA Enforcement Actions for Labeling
Content, Submission, Timing, FDA Review
Veterinary Medical Devices
Shared Jurisdiction with other Federal Agencies
FDA & USDA Split: Biologics
USDAs Animal and Plant Health Inspection Service
Virus Serum Toxin Act
Animal vaccines
Animal biologics
Animal disease diagnostic devices
The Case of Veterinary Stem Cell Therapy
EPA
Flea & Tick Products
Insect Repellants such as Equine Fly Sprays
Labels, Labeling, Marketing and Advertising
Labels, Labeling, Marketing and Advertising Issues
Labeling, Promotion and Advertising: Definitions and Examples
Labeling
Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label
Promotional Materials
Brochures, Press Releases, Flyers, Audio and Advertising
Written Media, Broadcast Media, Internet Media, Social Media
CVM Regulation of Labeling, Promotion and Advertising of RX Animal Drugs
Standards to Avoid Misbranding: Truthful, Substantiated, and Not Misleading
Timing of Marketing and Advertising Reviews
Post Approval Surveillance Requirements
Extra-Label Drug Use
Non-Approval-Related Considerations
Noncompliance and Enforcement
FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution
FDAs Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
Local, State, and Tribal governments
CVMs Office of Surveillance and Compliance
Types of Enforcement Actions
Warning Letters and Untitled Letters
Seizures
Injunctions
Monetary Penalties (21 USC 303 and 307)
Criminal Prosecution
Debarment
Park Doctrine Corporate Official Liability under FDCA
Overlapping Agency Jurisdiction FDA, DOJ, FTC, USDA, and State Agencies
Importance of Patent Protection: Right to Enforce
Protections against Competitors from Making, Using, Selling, Offering to Sell, or Importing Innovator Products
Enforcement
Patent Litigation of Veterinary Medicine
Post-Grant Proceedings Competitors May Use

Seminar Summary:

This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDAs veterinary drug approval process (see full course description)

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