Mark Gardner, M.B.A., J.D., Directing Attorney

Email     mgardner@gardner.law
Office    651.430.7150
Mobile   612.382.7584

Mark Gardner, MBA, JD, Directing Attorney, Gardner Law, has worked in FDA-regulated industry since 1999. He advises companies on a wide variety of topics including health care compliance, advertising and promotion review, FDA -regulatory, -quality, and -clinical matters, privacy, transparency reporting, and enforcement. He has been “seconded” to manufacturers such as Bayer Healthcare and Johnson & Johnson. Previously he worked in commercial roles, including product management, at ev3 (Medtronic), Celleration, and MedTox Laboratories (Labcorp).

Mark is an Adjunct Professor of Law at Mitchell Hamline School of Law where he teaches Drug & Device Law, sits on the Health Law Institute Advisory Board, and serves as a judge and coach for student competitions.

He has written and lectured extensively on a variety of topics relating to anti-fraud, FDA, transparency, and enforcement matters. Mark sits on the Section Council for the MSBA Food, Drug and Device Law Section. He previously served as Chair, Vice Chair and Secretary for the Section. Mark also sits on the FDLI Advertising and Promotion of Medical Products Conference Planning Committee. He previously served as Chair for the Medical Alley Regulatory Special Interest Group.

500

Clients Counseled

52

Ski Areas Visited

Mark Gardner

Executives today face a more rigorous and demanding regulatory environment than those that preceded them. My clients appreciate my prior industry experience and how I apply it in my practice. Since I’ve walked in the shoes of my clients, I understand the complex challenges they face.

– MARK GARDNER, M.B.A., J.D.

Practice Areas:

  • Health care compliance
  • Advertising and promotion review
  • FDA -regulatory, -quality, and -clinical matters
  • Privacy
  • Transparency reporting
  • Enforcement