Veterinary Products Caselaw and Emerging Trends: An Introduction

Access to recordings of virtual introductory courses is limited to one year from
the date of purchase as we update programs annually.

Role of caselaw in promoting safe and effective veterinary products and outlines key issues brought by litigation
Landmark decisions and their impact on industry, regulatory practices, and litigation trends
Unresolved legal issues and “what’s next” in animal product litigation

Patrick C. Gallagher, Principal, PC Gallagher Law P.A.
Karl Nobert, Attorney, Michael Best & Friedrich LLP

This session was recorded as part of FDLI’s Virtual Introduction to Veterinary Products Course in May 2024.

Get Access

$149

+$100 for nonmembers

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari. If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Virtual Learning FAQ

When will I receive my session?

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.

Is my computer/mobile device compatible?

On-demand content can be played back on most devices.

Is CLE credit available?

CLE credit is not currently available for pre-recorded sessions.

Related Content

Got Observations?: Ensuring Effective Responses to FDA 483s and Warning Letters

Orange You Glad You Learned About Teva v. Amneal?: A Watershed Case in Orange Book Listing

Introduction to Tobacco and Nicotine Law and Regulation: Recent Developments and Hot Topics Panel Discussion

Essential Vaccine Policy Updates: ACIP, CDC’s COVID-19 Guidance, and What’s Next

FDA and Medical Product Oversight: Assessing Recent Changes

The MAHA Agenda: Implications for Drug Pricing Reform

Tariff Shake-Up: The Impact on Drug and Device Access, Costs, and Manufacturing

Cosmetics and Children: Safety, Advertising, and Enforcement in the Era of Viral Products

Risky Business: Addressing 2025 Drug and Device Inspections

Beyond TTB’s New Proposed Rule: Future Directions in Alcohol Labeling Webinar

The New Leaf of Cannabis Regulation Webinar

The Results Are In: How the 2024 Election Outcomes Will Impact Healthcare Policies

An Introduction to Drug Enforcement: FDA Enforcement Authorities, Tools, Violations and Initiatives

Regulation of Drug Marketing: An Introduction

Regulation of Drug Manufacturing: An Introduction

Regulation of Over-the-Counter (OTC) Drugs: An Introduction

The Regulation of Biologics and Biosimilars: An Introduction

Post Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes

An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

The New Drug Approval Process: NDA Submission and Review

The New Drug Approval Process: New Drug Research and Development

The New Drug Approval Process: Basic Concepts

Origins and Overview of Drug Law Regulation: An Introduction

Stabilizing After the Stabilization Period: What to Expect From Further Implementation of DSCSA

International Issues for Medical Device Manufacturers: An Introduction

An Introduction to the Regulation of Promotion and Advertising for Medical Devices

FDA Authorities and Processes for the Enforcement, Compliance, and Inspection of Medical Devices

Regulatory Requirements for Medical Device Manufacturing and Quality System (QS) Regulation: An Introduction

Post Marketing Issues for Medical Devices: An Introduction

An Introduction to Coverage, Coding, and Payment of Medical Devices – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

Medical Device Premarket Approval Applications (PMA); Humanitarian Device Exemption (HDE) and Breakthrough Devices: An Introduction

An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests

Medical Device Clinical Investigations: An Introduction

Regulation of Digital Health Products: An Introduction

An Introduction to the Regulation of Combination Products for Medical Devices

Overview of Medical Device Law and Regulation

Case Studies and Practical Implementation, an Introduction to Medical Product Advertising and Promotion

Multi-Channel, Pre-Approval, and Non-Promotional Communication, an Introduction to Medical Product Advertising and Promotion

Beyond FDA, An Introduction to Medical Product Advertising and Promotion

Core Fundamentals, an Introduction to Medical Product Advertising and Promotion

FDA Regulatory Authority, an Introduction to Medical Product Advertising and Promotion

Introduction to Tobacco and Nicotine Law and Regulation: Inspections and Enforcement

Introduction to Tobacco and Nicotine Law and Regulation: Product Compliance

Introduction to Tobacco and Nicotine Law and Regulation: The Public Heath Standard

Introduction to Tobacco and Nicotine Law and Regulation: Pathways to Market and Related FDA Processes

Introduction to Tobacco and Nicotine Law and Regulation: The Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Regulation

Hatch–Waxman at 40: A Critical Examination of its Past and Future

Advancing the Mission: Former FDA Chief Counsels on FDLI’s Future as a Resource for the Bar

Food and Dietary Supplement Imports and International Issues: An Introduction

FDA Inspection and Enforcement Authority for Food and Dietary Supplement Manufacturers

Food Advertising: An Introduction to the Federal Trade Commission and Private Rights of Action

Food Labeling: An Introduction to Nutrient Content, Health, and Other Claims

Food Labeling: An Introduction to General Requirements (Including Meat and Poultry)

The Regulation of Dietary Supplements: An Introduction

Foods Developed Using Biotechnology and Animal Cell Culture Technology – US Regulatory Oversight

An Introduction to U.S. Department of Agriculture Labeling, Inspection and Ingredient Approval Requirements

Food Safety: Current Good Manufacturing Practices and Related Requirements; Unintended Components/Contaminants of Food

Food Safety: An Introduction to Ingredient Preclearance/Intentional Components of Food

The Regulation of Cosmetics: An Introduction

Overview of U.S. Food Law and Regulation: An Introduction

The Fate of FDA Authority: Addressing Recent Supreme Court Decisions on Mifepristone, Chevron, and Beyond

High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling

Decoding FDA’s New Rule on LDTs: Insights, Implications, and Legislative Considerations

Veterinary Products Caselaw and Emerging Trends: An Introduction

An Introduction to Animal Food, Feed, and Supplements Requirements and Challenges

An Introduction to Veterinary Drug and Device Requirements and Challenges

Veterinary Product Regulation: An Introduction to the Roles and Responsibilities of FDA and USDA

Veterinary Products: An Introduction to the Federal Regulatory Landscape

An Introduction to Laws Governing Veterinary Products

Social Media Spotlight: FDA Compliance for TikTok, X, LinkedIn, and Other Content

Federal Cannabis Regulation: Current FDA and Stakeholder Perspectives

Cosmetic Safety and Contaminants: PFAS, State Versus Federal Regulation, and More

An Introduction to Violations, Enforcement, and International Issues in Biologics and Biosimilars

The Regulation of Biological Product Marketing: An Introduction

The Regulation of Biological Product Manufacturing: An Introduction

Post-Approval Pharmacovigilance of Biological Products: An Introduction

Biologics and Biosimilars: An Introduction

Biological Product Approval, Vaccines, Emergency Use Authorization: An Introduction

Introduction to Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy

Regulation of Biological Product/Drug Development: An Introduction

Introduction to FDA Review and Approval of Biological Products

Overview of Biological Products Law and FDA’s Regulatory Processes

USPTO-FDA Collaboration: Progress Towards Patently True Interagency Coordination

Enhancing Engagement Opportunities and Communication with FDA

Collaboration Across Agencies: Understanding the Role of FDA, USDA, and EPA in Food Regulation

Current Trends in FCPA and FCA Enforcement: Identifying Fraudulent Practices and Mitigating Risk

Recent Rulings on Mifepristone Access: Implications for FDA and Stakeholders

Meet MoCRA: Getting to Know the Modernization of Cosmetics Regulation Act

Psychedelics Meet Mainstream Medicine: Overcoming Regulatory Uncertainty and Addressing Patient Safety Challenges

The Drug Supply Chain Security Act: Implementation Challenges, Industry Compliance, and Best Practices

Advocacy Without Antagonism: Principled Counseling in Food and Dietary Supplement Class Actions

Implementation of the Inflation Reduction Act: Healthcare Reform and Implications for the Pharmaceutical Industry

The Future of Food Regulation: Assessing the Reagan-Udall Foundation’s Report on FDA’s Human Foods Program

Fundamentals of FDA Regulation of Cosmetics

FDLI Book Launch—How FDA Really Works: Insights from the Experts

Supply Chain Mayhem: Industry Impacts and What Can be Done

Updates and Developments in Drug Compounding

Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution

Essentials of Inspection Readiness for Medical Products

Essentials of FDA, DOJ, FTC Enforcement Authorities

You Can’t Outsource Responsibility: Managing Quality in a Contract Manufacturing Partnership

Over-the-Counter Drugs Monograph Reform – How’s it Going?

FDA’s COVID-19 Activities

FDA’s Expedited Programs: Understanding Which Program Best Suits Your Product

Food Law in China: Overview, Practical Considerations, and Recent Developments

FDA and Alcohol: Trends in Alcoholic and Alcohol-Free Products, Regulatory Framework, and Marketing and Labeling Compliance

The Promise and Problem of Blockchain for Medical Products: What Lawyers Need to Know

Understanding Synthetic Nicotine: A Comprehensive Scientific and Legal Review

Navigating the Complexities of Combination Product Regulation

Medical Device Clinical Investigations: An Introduction to Sponsor Responsibilities and Compliance Issues

Medical Device Manufacturer Requirements: An Introduction to Registration and Listing of Establishments

FDA and Centers for Medicare and Medicaid Services: Regulatory Considerations for Communicating and Contracting for Value

Best Practices for Drug Recalls

The Hazy Legal Status of Delta-8 THC and Other Chemically Modified Cannabinoids

The Essentials of Food Science

Machine Learning for Regulatory Attorneys and English Majors

The Essentials of Tobacco and Nicotine Product Research

The Essentials of Statistics for Medical Products Lawyers

Food and Dietary Supplement Class Action Litigation: Roundtable Discussion on Recent Filings and Current Trends

The Essentials of Clinical Trial Science

How Does FDA’s Recent Guidance on Remote Interactive Evaluations Change the Inspections Landscape?

Biologic and Biosimilar Litigation and IP Rights

The Impact of COVID-19 on the In Vitro Diagnostic Industry

Prop 65 Trends and Issues: Food and Dietary Supplements

Biosimilars: Regulatory Challenges and Barriers to Entry

CBD and Other Hemp-Containing Pet Products: Regulatory and Enforcement Considerations

Examining the State of Drug Importation and Drug Pricing

Food For Thought: Functional Foods and Nutrition-Based Communication

FDA’s Legal Authority Over Laboratory Developed Tests

Compounding Drug Products Due to Supply Chain Access in Light of COVID-19

FDA’s Compounding Memorandum of Understanding with States: Questions, Concerns, and What’s Next

Continued Reliance on Foreign Drug Manufacturing and the Drug Supply Chain: Manageable Risk or Public Health Concern?

Tobacco-Free Nicotine Products: Evolution, Research, and Remaining Concerns

Reviewing FDA’s Recently Released New Era of Smarter Food Safety Blueprint

State of FDA Medical Product Manufacturer Inspections During and After COVID-19

Restarting Clinical Trials in the Wake of COVID-19

COVID-19 and Tobacco and Nicotine Products: Enforcement Disruptions, Industry Impact, and Possible Links Between Product Usage and Contracting or Worsening the Illness

What Does Current Cannabis Research Tell Us and What Are Future Prospects for Research Access?

Animal Drug Compounding: FDA’s New Guidance and Impacts on Industry

COVID-19 and Beyond: Development and Implementation of Recovery Action Plans for Medical Product Manufacturers

The Long-Awaited Biologics Transition Date Has Come: What Now?

FDA’s Recent COVID-19 Guidances Facilitating Expanded Access to Certain Medical Products

COVID-19 and Beyond: Crisis Preparation, Management, and Recovery in the Food and Dietary Supplement Industries

What are FDA’s Tools for Responding to Public Health Emergencies Such as the Coronavirus (COVID-19)?

FDA-Related Congressional Committees: Jurisdiction, Focus, and Roles

Nicotine: What it Is, What it Does, and How to Effectively Communicate this Information to the Public

The CREATES Act Has Passed: What Does It Mean for the Generics Industry?

The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps

A Practical Guide to Bringing a Dietary Supplement to Market

Reducing Anti-Kickback Risks Associated with Medical Products

Introduction to the Regulation of Cannabis-Derived Products

Introduction to Product Liability Regarding FDA-Regulated Products

Due Diligence: Ensuring Your Deal Doesn’t Collapse Due to Regulatory, Clinical, Quality, or Data Integrity Issues

Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges

New Management Standards for Hazardous Waste Pharmaceuticals and Nicotine

Prop 65: Emerging Issues in California’s Law

Patient Assistance Programs: Recent Enforcement and Best Practices

Opioid Legislation: The Path Forward for FDA and DEA Webinar

From Approval to Coverage – FDA and CMS Jurisdictional Lines

Guidance on Guidance: FDA, DOJ, and Enforcement

Drug Pricing for the Food and Drug Community

Cell-Based Meat and Other Modified Foods

Organic Chemistry for the Food and Drug Community

USDA’s Proposed Bioengineered Food Disclosure Standard

DEA Law for the Food and Drug Community

Data Integrity: FDA Enforcement and Risk-Reduction Considerations

First Amendment Issues in Advertising and Product Packaging Webinar

New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures

Real World Evidence: Data Requirements, Utilization, and Presentation

Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for Industry

Development of Medical Devices: Best Practices for Safeguarding Your IP and FDA Rights

FDA, USDA, and EPA: Inter-Agency Overlap and Jurisdictional Boundaries

PDUFA and BsUFA Reauthorization: Key Changes Affecting Industry and Patients

Regulation of Cannabis in FDA-Regulated Products

The EU’s New Medical Device and IVD Regulations

REMS: Key Issues and Best Practices

Compounding Still in the Mix: Title I of the DQSA, the Compounding Quality Act, Three Years Later

False Claims Act Enforcement

Recent FDA Guidance Documents on Manufacturer Communications about Medical Products

21st Century Cures Act

The Yates Memo: A Lawyer’s Professional Responsibility

Social Media: Innovative Uses and Practical Experiences

Mandatory GMO Labeling: Preparing for Implementation

New FDA Nutrition Facts Label: Implications for Industry

New Changes to California’s Prop 65: What Do They Mean for You?

Open Payments Data and the Sunshine Act: Managing the Risk of Transparency

Marijuana Regulation in the Food and Drug Realm

admin2024-08-16T10:22:55-04:00