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

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

  • Published: September 2014
  • 2 Days
  • Compliance Online

Where: Chicago, IL (Venue to be announced shortly)

When: September 18-19, 2014

The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. Not all products intended for animal use are regulated by FDA. 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 Agriculture’s 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 a comprehensive understanding of FDA’s 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 READ MORE >

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

FDA’s purpose and mission

FDA’s jurisdiction

FDA’s 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)
FDA’s operation
Structure of FDA: Specifics of CVM
- CVM’s Mission
- CVM’s Jurisdiction
- nCVM’s 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 FDA’s 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

USDA’s 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

FDA’s Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy
- Local, State, and Tribal governments
- CVM’s 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

Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC

Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

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