Jay Sitlani

Mr. Jay Sitlani

Senior Regulatory Counsel & Chair, CDER Exclusivity Board
US Food and Drug Administration (FDA) / Center for Drug Evaluation & Research

Jay Sitlani has practiced FDA law since 2003 with a focus on all aspects of the "Hatch Waxman Act," the seminal 1984 US law that created the contemporary competitive landscape against which innovator and generic drug companies seek market entry in the United States. As a Hatch Waxman attorney, Mr. Sitlani has counseled companies on pharmaceutical patent matters and regulatory exclusivity issues. At the FDA, Mr. Sitlani chairs the Exclusivity Board, an interdisciplinary entity that addresses market and data exclusivity protections for innovator drug companies.

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