Michael M. Gaba - Lawyer in Washington, DC

Michael M. Gaba is a partner in the Washington, D.C., officeof Holland Knight where he is the federal policy leader of the firmsnational Healthcare Life Sciences Team. His regulatory and legislativelife sciences practice includes counseling and representing medical device andbiotech companies before the U.S. Food and Drug Administration (FDA), theCenters for Medicare and Medicaid Services (CMS) and the U.S. Congress. Mr. Gabaadvises clients on a wide range of regulatory issues related to FDA reform andefficiency, with an emphasis on proper implementation of FDAMA, FDAAA, andFDASIA. He also provides pre-market strategic counseling and post-marketsurveillance and enforcement advice, with a particular focus on combinationproduct approval, labeling and promotion. Helping clients get to market and staythere, Mr. Gaba counsels medical device and biotech companies on coverage,coding and reimbursement strategies before CMS to enhance patient access toinnovative technologies.

Mr. Gaba writes extensively and lectures on a numerous regulatory issues,including comparative effectiveness, interagency coordination and its impact inthe post-market context, defending FDA enforcement actions, as well as coverage,coding and reimbursement strategies for medical device manufacturers.

Prior to joining Holland Knight, Mr. Gaba worked on Capitol Hill in thepersonal offices of Congressman Robert Garcia (D-NY) and Senator Bill Bradley(D-NJ), and on the Labor and Human Resources Committee for Senator EdwardKennedy (D-MA).