Former FDAer Linda S. Carter Joins Hyman, Phelps & McNamara, P.C.

Hyman, Phelps & McNamara, P.C. is pleased to announce that Linda S. Carter has joined the Firm as a Regulatory Scientist. Linda, who will primarily assist HP&M’s drug development group, brings significant experience and expertise in shaping regulatory policies, particularly Comparative Effectiveness Research, Personalized Medicine, and Evidence-Based Medicine.

“I have had the pleasure to have worked alongside of Linda while we were both at FDA and have always been impressed with her sophisticated understanding of the FDA drug review system. We are thrilled to welcome Linda to our HP&M family in order to even better enhance our services to our drug sponsor clients, and through them, to patients,” said Frank J. Sasinowski, Director.

From 1984-2002, Linda worked for FDA, during which time she served as Associate Director of Regulatory Affairs in the Office of Drug Evaluation I in the Center for Drugs Evaluation and Research, and as Regulatory Policy Advisor in the Office of Review Management (now the Office of New Drugs), CDER. During her tenure at FDA, Linda received many awards, including the FDA Award of Merit and the Commissioner’s Special Citation.

Prior to joining HP&M, Linda served in several pharmaceutical industry positions, including as Senior Director, Global Regulatory Policy and Intelligence, Janssen Pharmaceutical Companies of Johnson & Johnson, Executive Director, FDA Liaison, Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation, and Director, Global Regulatory Affairs, Legislative Policy and Regulatory Liaison, Pharmacia Corporation.