Paul S. Gadiock - McDermott Will & Emery


Paul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, drug compounders, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes.

From providing strategic regulatory direction at the product concept stage through post-marketing issues such as product marketing, labeling, advertising, and recalls and crisis matters, Paul has substantial experience helping his clients bring novel technologies and innovative products to market and maintain competitive advantages. His deep experience allows him to provide practical, business-minded due diligence support to buyers, sellers and investors in achieving their transaction goals.

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  • Represented clients before the FDA on several occasions, successfully persuading the agency to decline regulating client medical products and wellness tools, often after the clients had received regulatory inquiries from FDA*
  • Advised an emerging pharmacy on drugs eligible for compounding under FDA law and performed regular labeling and advertising reviews, enabling the client to market its compounded medications compliantly and expand operations into new territories.*
  • Secured priority regulatory designation for a tissue product client, enhancing FDA interactions and expediting regulatory review of the tissue product’s marketing application*

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University of Maryland Francis King Carey School of Law, JD, 2009
University of Maryland, BS, 2004