Philip Katz

Philip Katz is a partner in the Life Sciences Regulatory practice at Paul Hastings and is based in the firm’s Washington, D.C. office. He counsels pharmaceutical and biotechnology clients on FDA regulatory matters across the product life cycle. Having led the Band 1-ranked Pharmaceuticals and Biotechnology Regulatory practice at his previous firm, Phil brings deep regulatory knowledge and understanding of agency processes that enable him to advise clients of all sizes on their most business-critical regulatory matters. His clients range from startups developing their first product to large public companies with extensive product portfolios.

Much of Phil’s work involves providing strategic guidance on FDA engagement and advocacy in the approval process for new drugs and biologics, obtaining and using regulatory exclusivities, and helping clients navigate compliance matters, enforcement activities and business transactions involving FDA-regulated products.

Phil has particularly extensive experience with the Hatch-Waxman Act, Orphan Drug Act and Biosimilars Price Competition and Innovation Act. His knowledge of the law, business considerations and FDA precedents provides the basis for working with clients to develop and implement creative, practical and effective strategies to obtain approval for products and address post-market compliance issues in a highly regulated environment in which long-term relations with the FDA are essential.

Georgetown University Law Center, J.D.

University of Virginia, B.A.