Michael M. Gaba is a Partner in the Washington, D.C., office of Holland & Knight where he is the federal policy leader of the firm’s national Healthcare & Life Sciences Team. His regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the U.S. Congress.
Mr. Gaba advises clients on a wide range of regulatory issues related to FDA reform and efficiency, with an emphasis on proper implementation of FDAMA, FDAAA, and FDASIA. He also provides pre-market strategic counseling and post-market surveillance and enforcement advice, with a particular focus on combination product approval, labeling and promotion. Helping clients get to market and stay there, Mr. Gaba counsels medical device and biotech companies on coverage, coding and reimbursement strategies before CMS to enhance patient access to innovative technologies.
Mr. Gaba writes extensively and lectures on numerous regulatory issues, including comparative effectiveness, interagency coordination and its impact in the 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 the personal offices of Congressman Robert Garcia (D-NY) and Senator Bill Bradley (D-NJ), and on the Labor and Human Resources Committee for Senator Edward Kennedy (D-MA).
He received his B.A. from Franklin & Marshall College and his J.D. from the George Washington University Law School.
Mr. Gaba is a co-author of the Bloomberg BNA Health Law & Business Portfolio Series No. 3250, Life Sciences Compliance: A Pre-Market and Post-Market Road Map.
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