Paula Katz

  PhotoPaula R. Katz, J.D., is Acting Branch Chief of Regulatory Policy and Collaboration in the Office of Manufacturing and Product Quality at CDER's Office of Compliance. Ms. Katz has served as Senior Policy Advisor and Regulatory Counsel on OMPQ's Policy and Guidance Team since 2009. She focuses on Agency policy related to Current Good Manufacturing Practice and drug quality issues. Ms. Katz frequently advises management and colleagues and speaks and writes on matters related to supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and strategy. Ms. Katz has chaired intra-Agency working groups and directed the drafting and publication of numerous draft and final guidances for industry and staff, proposed and final regulations, and legislation; managed and responded to Congressional and stakeholder inquiries; and served as a case officer and investigator in various domestic and international enforcement actions and case reviews. Prior to joining FDA, 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, and where she represented food and drug manufacturers and retailers, medical doctors, investors in the health care industry, and other regulated businesses and individuals.Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.