PRESCRIPTION OTC DRUGS AND BIOLOGICS
- OVERVIEW
- INSIGHTS
- NEWS & EVENTS
- PROFESSIONALS
RELATED BLOGS
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SERVICE AREAS
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RELATED PRACTICES
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RELATED INDUSTRIES
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REPRESENTATIVE CLIENTS
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Monsanto
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Nestle Purina Petcare
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Sigma-Aldrich
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University of Nebraska
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Thompson Coburn, having represented drug and biologic companies ranging from emerging technology to specialty pharma to the larger companies in the industry, understands that these companies are constantly under scrutiny and often targets of product liability litigation. This portion of the life science industry is heavily regulated making the cost to get to market and maintain market share difficult. Complying with Good Manufacturing Practices, working with clinical trial sites and Institutional Review Boards, and achieving approval to market is time-consuming and costly.
Our attorneys work with clients to navigate the regulatory waters consistent with their business strategies. For emerging technology and specialty pharma, we negotiate sensible and fair licensing agreements, negotiate with capital sources and provide intellectual property counseling. We have assisted our clients in:
- Filing New Drug Applications
- Filing Investigational New Drug Applications
- Filing for Orphan Designation
- Drafting and reviewing clinical trial agreements, protocols and informed consents, as well as advising the client on IRB interactions
- Complying with the Compounding Quality Act
- Negotiating regional and global licenses
- Reviewing BLA filings for sufficiency prior to filing
- Negotiating clinical trial agreements
- Negotiating tech-transfer agreements between research/academia and commercial entities
- Implementing strategies related to the detention of regulated products
- Responding to FDA 483 Inspection Reports and implementing corrective action plans where necessary
- Civil investigations and disputes with the FDA and FTC, including fraud and marketing claims
- Product liability cases regarding failure to warn, duty to warn, negligent manufacture and strict liability
- DEA licensing/registration issues
- FDA- and DEA-enforced pharmaceutical disposal matters
- Negotiating tech-transfer agreements between research/academia and commercial entities
- Compliance with the OTC monograph
Publications
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
Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers
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
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
ACI Drug and Medical Device Litigation Conference
Suzanne Galvin Quoted in Bloomberg Law Regarding Revised PFAS Settlement
World Trademark Review names Tom Polcyn to WTR 1000 list
Thompson Coburn releases 2021 Ag Innovation Survey on the impact of COVID, future of the ag industry
Jennifer Post talks to Business Insider about startup considerations before going public
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
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
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Senior Counsel
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St. Louis
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Gordon is a highly experienced trial attorney who has achieved significant courtroom wins for clients in cases involving commercial disputes, white collar criminal defens... Gordon is a highly experienced trial attorney who has achieved significant ... |
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Partner
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St. Louis
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Matt represents major agricultural companies in business-critical disputes. Matt represents major agricultural companies in business-critical disputes.... |
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Partner
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St. Louis
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Companies navigating the complex regulatory landscape of the food and beverage industry turn to Kim Bousquet for her experience handling disputes and providing guidance. Companies navigating the complex regulatory landscape of the food and bever... |
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Partner
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St. Louis
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Matt is vice chair of the Intellectual Property Practice Group. Matt is vice chair of the Intellectual Property Practice Group. |
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Partner
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St. Louis
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Dan Cox is a litigator handling sophisticated business, tort, product liability, intellectual property, and class action defense cases. Dan Cox is a litigator handling sophisticated business, tort, product liabi... |
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Senior Counsel
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St. Louis
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Chip's practice focuses on the representation of individuals, universities, and national and international companies in commercial transactions and counseling involving t... Chip's practice focuses on the representation of individuals, universities,... |
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Partner
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St. Louis
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John represents domestic and international clients in complex litigation and multi-district litigation in some of the most challenging state and federal venues in the cou... John represents domestic and international clients in complex litigation an... |
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Partner
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St. Louis
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Clients turn to Suzanne Galvin for results in complex high-profile litigation, particularly in the areas of pharmaceutical, medical device, and environmental exposure cla... Clients turn to Suzanne Galvin for results in complex high-profile litigati... |
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Partner
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St. Louis
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Wil has a PhD in cellular and molecular biology and experience as research scientist working for a major biotechnology company. Wil has a PhD in cellular and molecular biology and experience as research ... |
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Senior Counsel
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Washington, D.C.
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Benjamin is a corporate advisor and business strategist for a wide variety of privately-held businesses, manufacturers, financial institutions, and nonprofits. Benjamin is a corporate advisor and business strategist for a wide variety ... |
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Partner
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St. Louis
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David strategically advises clients in a variety of intellectual property disputes including patent prosecution, IP litigation, brand protection, counterfeiting, Post-Gra... David strategically advises clients in a variety of intellectual property d... |
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Partner
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New York
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James serves as legal adviser to investors, entrepreneurs, investment advisers and investment bankers as they fund or invest in new companies, grow established private co... James serves as legal adviser to investors, entrepreneurs, investment advis... |
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Partner
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St. Louis
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Tom is Co-Chair of Thompson Coburn LLP's Corporate Department. Tom is Co-Chair of Thompson Coburn LLP's Corporate Department. |
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Partner
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St. Louis
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Jeff is a litigator, former crop consultant, and agronomic crop specialist. Jeff is a litigator, former crop consultant, and agronomic crop specialist.... |
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Partner
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St. Louis
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Chris is a valued strategic partner to emerging companies and the institutions and individuals that invest in them. Chris is a valued strategic partner to emerging companies and the instituti... |
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Partner
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St. Louis
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Steve advises clients on domestic and international patent applications and provides comprehensive counsel on licensing and technology transfer. Steve advises clients on domestic and international patent applications and... |
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Partner
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St. Louis
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Ben brings a background in electrical and computer engineering to his legal practice, which primarily focuses on the preparation and prosecution of patent applications. Ben brings a background in electrical and computer engineering to his legal... |
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