About the Author
Philip Katz is a partner in the Washington, D.C., office of Hogan Lovells, where he is a Practice Area Leader of Hogan Lovell’s Pharmaceutical and Biotechnology Practice Group. He advises companies, trade associations, and individuals in matters involving regulation of drugs (both Rx and OTC) and biologics by the FDA and related federal and state agencies. His clients range from large public companies with mature product portfolios to startups that have yet to bring a product to market. He counsels them on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf before the FDA, other agencies, and in court.
His practice includes a particular focus on issues involving product development, approval, and life cycle management, including application of the Hatch-Waxman Act, Orphan Drug Act, and the Biosimilars Price Competition and Innovation Act. Phil also has extensive experience responding to agency enforcement activities, particularly in the areas of advertising and promotion, cGMP, and clinical trials, and he regularly provides strategic counsel in business transactions.
He is a member of the Board of Directors of the Food and Drug Law Institute, and of the Editorial Advisory Board of the Food and Drug Law Journal. He received a BA, with distinction, from the University of Virginia, and a JD, magna cum laude, Order of the Coif, from Georgetown University Law Center.
October 3, 2012 | By Philip Katz
“There are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns–the ones we don’t know we don’t know.”
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