Roshan P. Shah, MD, JD

I am serving as a Washington Health Policy Fellow from 2011-2012, during my fourth year of residency at the University of Pennsylvania. I am interested in Food and Drug Administration (FDA) issues. Having worked with a former FDA Commissioner, studied its policies and role during its tobacco control efforts, and discussed its legal mandate and case-law boundaries in law school, I have an appreciation for this agency and its oversight over product safety. I am also interested in the sometimes unclear relationship between the agency and physicians, notably over medical decision-making. Misconceptions between FDA approval and clearance, off-label use, and permissible medical care should be addressed. I am primarily interested in the 510(k) clearance pathway and will focus much of my work this year on issues surrounding its evolution.

Recent Publications

1. Shah RP, Lindsey DP, Sungar GW, McAdams TR. An Analysis of Four Ulnar Collateral Ligament Reconstruction Procedures with Cyclic Valgus Loading. Journal of Shoulder and Elbow Surgery 18:58-63, 2009.
2. Ionescu LC, Lee GC, Garcia GH, Zachry TL, Shah RP, Sennett BJ, Mauck RL. Maturation State-Dependent Alterations in Meniscus Integration: Implications for Scaffold Design and Tissue Engineering. Tissue Engineering Part A [online ahead of print], 2010.
3. Stuffmann ES, McAdams TR, Shah RP, Yao J. Arthroscopic Repair of the Scapholunate Interosseous Ligament. Techniques in Hand & Upper Extremity Surgery 14: 204-208, 2010.
4. Baker BM, Shah RP, Huang AH, Mauck RL. Dynamic Tensile Loading Improves the Functional Properties of MSC-Laden Nanofiber-Based Fibrocartilage. Tissue Engineering (accepted, forthcoming).