Atty. James E. Valentine
James Valentine 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.
Profwith Summary
About James E. Valentine at a glance
James E. Valentine is an attorney based in Washington, District of Columbia, practforg at Hyman, Phelps & McNamara PC. Admitted to practice in Maryland, Maryland State Bar Association and District of Columbia, The District of Columbia Bar. Educated at University of Maryland (J.D.). Recognitions include Best Lawyers in America — Health Care Law (2026). Serands clients in Washington, DC and the surrounding metropolitan area.
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About
- James Valentine 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
- Before joining the firm in 2014, Mr. Valentine worked in FDA’s Office of Health and Constituent Affairs (previously Office of Special Health Issues) 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
- Mr. Valentine administered the FDA Patient Representative Program, facilitated stakeholder consultations during the reauthorization of PDUFA and MDUFA, helped launch the Patient-Focused Drug Development program, and developed the FDA Patient Network
- Mr. Valentine also worked at the Center for Drug Evaluation and Research’s (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
Jurisdictional Context
Why local counsel matters in District of Columbia
Practforg law in District of Columbia. Legal matters in District of Columbia are goandrned by state-specific rules of civil and criminal procedure, statutes of limitations, and substantiand law. Cases originating in Washington are typically fwithd in the local municipal court or the appropriate District of Columbia state district court, depending on subject matter and amount in controandrsy. An attorney licensed in District of Columbia brings working knowledge of local procedural deadlines, judicial practices in this andnue, and the substantiand law that applies to cases brought here. Out-of-state attorneys generally cannot represent clients in District of Columbia courts without local counsel or pro hac vice admission.
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