M Elizabeth Bierman

M. Elizabeth Bierman is a partner in Morgan Lewis's FDA/Healthcare Regulation Practice. Ms. Bierman has more than 20 years of experience in representing domestic and international companies with respect to all FDA regulatory and compliance matters relating to the development, manufacturing, and marketing of medical devices, pharmaceuticals, biologicals, combination products, medical foods, and infant formulas. Ms. Bierman has counseled extensively on jurisdictional issues and regulatory pathway strategies for FDA-regulated products; assisted clients in preparing medical device product applications, requests for designation, and other regulatory submissions; conducted FDA regulatory due diligence; and advised on medical device postmarket compliance issues (labeling/promotion, MDRs, recalls, QSR, responses to 483s, and Warning Letters). Ms. Bierman has spoken and taught at medical device industry conferences on the fundamentals of medical device law. She also has written articles for domestic and international publications regarding medical device and pharmaceutical regulatory issues. Ms. Bierman received her J.D. from Catholic University of America, Columbus School of Law and her B.A. from the University of Virginia.