This content is provided by Philip Katz.
Philip Katz helps pharmaceutical and biotechnology companies successfully navigate U.S. Food and Drug Administration (FDA) and related regulatory matters. He works with them to anticipate and address regulatory issues in their day-to-day business operations and strategic planning; counsels them on compliance; and advocates for them before FDA, other agencies, and in court. Much of his work involves product development, approval, and regulatory exclusivities. His clients develop, manufacture, and distribute drugs and biologics, spanning from large public companies with extensive product portfolios to startups trying to bring their first product to market. Phil heads the firm's Pharmaceutical and Biotechnology
Regulatory Law practice group.