Regulatory Attorney

Our firm's regulatory attorney's regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the U.S. Congress. More specifically, he has worked on a range of issues related to health care reform with an emphasis on HHS integration, the FDA Amendments Act, post-market surveillance and enforcement, with a particular focus on combination product approval and labeling, as well as coverage, coding, and reimbursement for these sophisticated products.

Our specialist also represents national not-for-profit organizations before the legislative branch and the National Institutes of Health on health care policy and funding matters, and writes extensively and lectures on a range of health care issues, including comparative effectiveness, interagency coordination and its impact in the post-market context, defending FDA enforcement actions, as well as on coverage, coding, and reimbursement strategies for medical device manufacturers. Our specialist is conveniently based in Washington, D.C.

Contact us to learn more