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James Valentine

Hyman, Phelps & McNamara, PC, United States
Washington D.C. Metro Area
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara 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 has been central to the transition of the FDA Patient-Focused Drug Development (PFDD) program to externally-led meetings, having helped plan and moderated the majority of those, and is also working on novel methodologies for capturing patient experience data. Mr Valentine has also authored an analysis cataloguing FDA's flexibility in assessing efficacy in the approval of drugs for rare, or orphan, conditions.