James Valentine

Adjunct Professor

Associate Attorney, Hyman, Phelps & McNamara, P.C.



Photo of James Valentine

James E. Valentine is an Associate Attorney with Hyman, Phelps & McNamara, P.C., where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine also works with clients on clinical trials operations and compliance matters. As an Adjunct Professor at the University of Maryland School of Law, he teaches a course in food and drug law.

Prior to joining the firm in 2014, Mr. Valentine worked for the U.S. Food and Drug Administration (FDA) Office of the Commissioner where he facilitated patient input in benefit-risk decision-making and served as a liaison to stakeholders on a wide range of regulatory policy issues. He also worked at the FDA Center for Drug Evaluation and Research (CDER) Office of Regulatory Policy where he coordinated the implementation of the medical gases certification scheme that was established in FDASIA and handled a variety of postmarket safety issues including REMS and safety labeling changes.

Mr. Valentine has several journal articles, book chapters, and presentations to his credit, advancing the regulatory science around rare disease product development and patient engagement in regulatory decision-making. In 2019, he was recognized for his advocacy work, honored by Global Genes, an international non-profit rare disease patient advocacy organization, as a RARE Champion of Hope.

Mr. Valentine received his B.A. in Interdisciplinary Studies from the University of Maryland Baltimore County, M.H.S. in Health Policy from the Johns Hopkins School of Public Health, and J.D. with Health Law Certificate from the University of Maryland School of Law. He is admitted to practice in Maryland and the District of Columbia.