Mark Paxton, JD CDER, FDA

Mark Paxton is a Regulatory Counsel at Center for Drug Evaluation and Research (CDER), FDA. Previously, he served as the Associate Vice President for International Regulatory Affairs for Pharmaceutical Research and Manufacturers of America (PhRMA) in Washington, DC. In this role, Mr. Paxton served as the primary industry person responsible for establishing global regulatory priorities and works with high level, company regulatory experts in a number of regulatory and technical committees to develop and implement global regulatory strategies, and engaged foreign Regulatory Authorities from Japan, Europe, Pacific Rim, and Latin America to position PhRMA objectives. Before joining PhRMA, Mr. Paxton was a pharmaceutical consultant providing expertise in approval requirements for 505(b)s and 505(j)s, Citizen/Suitability petitions, as well as manufacturing compliance requirements. Mr. Paxton received a BS in Business and Economics and a MS in Economics from the University of Kentucky and a JD from the University Of Dayton School Of Law.