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Consultant

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FDA

Michael M. Gaba

Michael Gaba helps medical device, pharmaceutical and biotech companies navigate and eliminate regulatory barriers to market often times posed by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). Drawing upon more than 25 years of experience addressing challenges at both agencies, which at times includes working with the U.S. Congress and the Administration, Michael prides himself on being a problem solver, consulting with clients to define pre-market pathway options, avoid or resolve post-market compliance issues and create coverage, coding and reimbursement solutions.