Paula Katz

Paula R. Katz, J.D., is Director of Manufacturing Quality Guidance and Policy in CDER’s Office of Compliance. She leads an interdisciplinary staff of senior compliance officers and technical experts who focus on CGMP enforcement and drug quality policy issues. Ms. Katz frequently advises Center and Agency leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy. Ms. Katz has chaired Agency working groups and directed the development of guidance for industry, regulations, and legislation; managed responses to Congressional oversight and other stakeholder inquiries; and conducted domestic and international inspections, case evaluations, and enforcement actions. She is a frequent presenter at industry and agency meetings, conferences, and training events. Prior to joining FDA in 2009, Ms. Katz was a litigation associate at a large law firm in Washington, D.C., where her practice included regulatory compliance, white-collar crime, and general commercial litigation. Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.