FDA Law

Sound business decisions require weighing many factors throughout your product’s life cycle, such as pre- and post-approval regulatory strategy, intellectual property enforcement or defense, and understanding your competition. Whether negotiating with the FDA or other third parties, resolving disputes, or providing advice for protecting and supporting your business through the tangle of statutory/regulatory obligations you face, helping your business thrive is our top priority.

Navigating FDA laws requires strategies tailored to specific industries. When you work with Carlson Caspers, you access a firm with a deep understanding of and expertise in the following areas where the impact of the FDA is significant:

• Medical Devices
• Pharmaceuticals, Biosimilars, and Nutraceuticals
• Polymers, Chemicals, and Compositions

Our team’s comprehensive understanding of these industries enables us to develop customized regulatory and compliance strategies that align with your company’s objectives and help mitigate risks of non-compliance. We stay ahead of emerging FDA trends and challenges, ensuring your business is prepared for any new regulatory development.

A digital presence is a vital element of corporate strategies today, and the reliance upon these channels and digital assets will continue to grow exponentially. The stakes and threats, as are the rewards, are exceptionally high in FDA regulatory compliance. Carlson Caspers supports clients in navigating digital compliance challenges, a growing concern for pharmaceutical and biotechnology companies like yours.

The Carlson Caspers pharmaceutical and biotechnology FDA Regulation and Compliance practice focuses on helping companies navigate the intersections of intellectual property, patent infringement and litigation, FDA law, and the drug supply chain. Spearheaded by individuals with a combination of pharmaceutical industry experience and extensive courtroom work, we are uniquely qualified to understand your business and legal challenges stemming from FDA regulations.

Also, our deep understanding of the drug supply chain, from payors to manufacturers, enables us to advise you on critical issues such as product labeling, regulatory approvals, and distribution strategies. We work closely with your team to address your most complex challenges in regulatory compliance, intellectual property protection, and ensuring smooth and equitable market access.

Since our firm’s inception, Carlson Caspers has emphasized working with our clients as a team. The results speak for themselves when you look at how effective our communications are and how we align our efforts to deliver your corporation’s desired outcome.

Customized Strategies Aligned with Your Business Goals: Carlson Caspers collaborates closely with our clients to craft compliance, litigation, and appeal strategies designed for rapid, effective results in FDA regulatory matters. We start by understanding your priorities and unique needs, then tailor our approach to focus on early resolutions wherever possible.

You’re on Our Team: Carlson Caspers’ attorneys operate as a cohesive team, leveraging each other’s strengths and drawing on exceptional industry understandings to deliver comprehensive support that aligns with your needs. We actively involve you in our team and collaborate closely with your subject-matter experts, blending our expertise in FDA regulatory compliance with your in-depth understanding of your products, competitors, and strategic objectives. This proven, team-based approach delivers the best possible outcomes in any FDA regulatory compliance case.

Stewards of Your Resources: Carlson Caspers is dedicated to managing resources efficiently and balancing robust case management with a cost-conscious approach. By aligning our strategies with your business goals, we aim to reduce legal expenses measured in time, financial outlays, and other corporate resources.

Carlson Caspers has a strong track record of successfully representing pharmaceutical companies in complex FDA regulation and compliance matters. Notable examples include:

• Takeda Pharmaceutical Company v. Sun Pharma Global FZE: Carlson Caspers secured a Federal Circuit affirmance of a judgment of noninfringement for Sun Pharma regarding the anti-ulcer drug Prevacid® SoluTab™.
• Abbott Laboratories, Inc. v. Teva Pharmaceuticals USA, Inc.: We represented Teva in challenging eight Abbott patents related to pharmaceutical products containing niacin and simvastatin (Simcor®), achieving favorable outcomes.
• Takeda Pharmaceutical Company Limited v. Sun Pharma Global FZE: Carlson Caspers defended Sun Pharma in a patent lawsuit concerning lansoprazole orally disintegrating tablets (Prevacid® SoluTab™), leading to favorable results.

These cases highlight Carlson Caspers’ expertise in navigating the intersections of intellectual property and FDA law, effectively addressing complex regulatory and compliance challenges for our pharmaceutical, biomedical, and other clients.

Carlson Caspers distinguishes itself from other firms through our deep understanding of the complexities of FDA regulatory compliance and our industry-specific expertise. We stay ahead of regulatory trends to help our clients navigate the ever-changing FDA regulatory landscape.

Whether you need guidance navigating demanding FDA compliance challenges, support in intellectual property disputes, or a strategy for aligning regulatory obligations with your business goals, you can trust Carlson Caspers for unmatched FDA regulatory compliance support and guidance. We seamlessly integrate legal insight, industry expertise, and a commitment to your success.