FDA Regulatory Counsel supports litigation involving FDA-regulated products and companies by adding insight on complex FDA issues. We provide subject matter expertise in product liability cases across the country and are practiced in navigating DOJ enforcement actions.


Representative Matters

  • Apply regulatory insight to global issues of fact and law

  • Advise on and conduct compliance-related discovery, including drafting interrogatories, taking depositions, and interpreting information and documents.

  • Support expert witness testimony.

  • Inform motions practice and trial proceedings on FDA-related issues.

Please contact us to see how we can support active or contemplated litigation.

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© 2020  by FDA Regulatory Counsel LLP


This site is not intended to be legal advice. Contacting the firm or reading the materials on the site does not create an attorney-client relationship. No confidential information should be sent over the internet. Past results do not predict future outcomes as each situation has to stand on its own. Melissa Gilmore is licensed to practice law in the District of Columbia, New York (inactive), and California (inactive). Donato J. Borrillo is licensed to practice law in Ohio.