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ANIMAL HEALTH

Animal health companies range from those that manufacture prescription drugs for large and small animals to pet foods. The industry is growing and attracting much of its management and financing from the human side. This presents new challenges as the FDA regulates animal health very differently than human health companies. Thompson Coburn counsels animal health companies on a diverse group of issues, including how to market a supplement-type product, the filing of New Animal Drug applications and filing for and receiving a MUMS designation.

For our animal health company clients we:

  • Advise and file New Animal Drug Applications
  • Advise and file for MUMS designation
  • Advise and file Animal Feed Additive Petitions
  • Act as regulatory counsel on initial public offerings
  • Negotiate license agreements from human health companies for animal health use
  • Advise on marketing and advertising compliance strategies
  • Advise on compliant manufacturing practice, including responding to FDA inspections
  • Counsel on medicated feed regulations, the animal drug development processes, and developing protocols for pivotal field studies
  • Counsel on recalls when tainted feed is suspected or confirmed
  • Counsel on FTC and FDA investigations into misbranded, mislabeled and adulterated products, as well as marketing claims
  • Counsel on issues related to obtaining animal vaccine approvals from the USDA
  • Counsel on import/export issues and foreign manufacturing facility compliance
  • Counsel on regulation of animal supplements
  • Counsel on mergers and acquisitions

    In addition, animal health companies, particularly those that are in the animal feed or supplement area, require assistance in understanding and complying with the new regulations that have been promulgated under the Food Safety Modernization Act. These new rules are complicated and require a new level of compliance, including analysis and documentation of hazards that are inherent in the manufacturing and packaging process and written plans to manage these hazards. We are counseling our clients on how to engage in this analysis and draft these plans.

Publications

Illinois legislature makes substantial limiting changes to state law on non-compete and non-solicitation agreements

EEOC issues new guidance on COVID-19 vaccinations in the workplace

Litigation fees may be tax-deductible, confirms new Tax Court ruling

Participate in standard-setting bodies? The enforceability of your patents could be affected

Criminal antitrust prosecutions still loom for employers with ‘no-poaching,’ ‘wage-fixing’ agreements

Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers

Supreme Court heralds tectonic shift in venue selection for patent suits

What to do when the government comes calling: A checklist for handling facility inspections

USPTO launches new proof of use audit program

The shifting standard for IPR estoppel: Where are we now?

5 tips for environmental due diligence in business transactions

D.C. appellate court strikes another nail in the coffin for the Frye test

What U.S. companies need to know about their IP rights post-Brexit

New OSHA reporting and anti-retaliation rules

USPTO publishes new (and largely improved) guidance for subject matter eligibility

Federal Circuit rules objective prong of willful infringement best decided by judge

TCLE

Better Together? Competition, Price Gouging and Other Antitrust Issues Raised by the COVID-19 Pandemic

Statutory Changes, New Regulations, and Compliance Deadlines Under the Food Safety Modernization Act

Blog Posts

Clearview AI class-action may further test CCPA’s private right of action

‘Aggrieved Persons’ can bring suit under Biometric Information Privacy Act

DOJ continues to investigate, seek recoveries over compounding pharmacy fraud

Fate of legalized cannabis hinges on key vote

FDA to step up enforcement of homeopathic medicine

Recreational marijuana shake-up: Sessions revokes Cole Memorandum

Clinical trials Part I: The upcoming clinical trials reporting rule

The FDA's new Digital Health Plan

FDA’s Health Software PreCert Program to fast-track innovation

FSVP compliance dates arrive, challenges to food industry increase

News

Jennifer Post talks to Business Insider about startup considerations before going public

Thompson Coburn releases first Ag Innovation Survey on the impact of COVID, future of the ag industry

Thompson Coburn supports agricultural growth through the Center for Soybean Innovation

Gain Executive Insights on trade developments with Thompson Coburn, Hispanic Chamber of Commerce

New Jersey jury awards $11 million to Thompson Coburn client in pet invention dispute

Agribusiness professionals enjoy hands-on farm simulation at Thompson Coburn

Thompson Coburn leads Missouri Soybean Merchandising Council to $600,000 jury verdict

Thompson Coburn earns corporate counsel recommendations five years running in national report

Jim Slear leads webinar on ‘Navigating the Russian and Ukrainian Sanctions Maze’

UMSL Research & Innovation Week to feature Tom Schlafly presentation

Steve Ritchey publishes article on patent basics for American Ceramic Society

Jeff Masson named ‘Influential Appellate Advocate’ for Monsanto Supreme Court win

Three partners named 2013 Up & Coming attorneys

Monsanto wins unanimous ruling from U.S. Supreme Court

19 Thompson Coburn partners named 2013 St. Louis Lawyers of the Year

Jeff Masson featured in AgProfessional magazine

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