Christopher M. Mikson M.D., J.D.

Chris Mikson is a medical doctor, registered patent attorney, and experienced litigator who advises and represents clients in Food and Drug Administration (FDA) regulatory matters and complex litigation and transactional matters involving healthcare and the life sciences.

Regulatory: Chris has extensive experience in the regulation of drugs, biologics, human cell and tissue products (HCT/Ps), and medical devices by FDA and other federal and state agencies. He has counseled and represented clients in regulatory matters across all stages of the product life cycle, from research and development to nonclinical testing, clinical trials, premarket clearance and approval, manufacturing and distribution compliance, and post-market surveillance and reporting, including a broad range of agency proceedings such as Orange Book listing disputes, comments during rulemaking, citizen petitions, establishment inspections, responses to agency letters, and enforcement actions. Chris has completed FDA’s Clinical Investigator Training and NIH’s Clinical Research Training, affording him a multi-disciplinary understanding of current and evolving regulatory conditions as well as state-of-the-art science and technology that are critical to the design, conduct, and ultimate success of clinical trials for small molecule drugs, biologics, HCT/Ps, and medical devices.

Litigation and Transactional: Chris has comprehensive experience in a broad range of complex litigation matters. He has represented some of the world's largest pharmaceutical, medical device, consumer product, and technology companies in patent infringement, trade secret, false advertising, and product liability litigation. Chris focuses his litigation practice on FDA regulatory disputes and cases where FDA regulation intersects with other areas of the law, such as product liability and intellectual property, including Hatch-Waxman and biosimilar cases. In addition to his litigation practice, Chris regularly performs transactional work related to FDA-regulated products, including material and service contracts, licensing agreements, and due diligence of major deals.