As chair of the firm’s Life Sciences Practice Group, Debra Dunne counsels FDA regulated companies on regulatory, commercial, compliance and risk-management issues, and litigates pharmaceutical and medical device commercial and products liability cases. Her practice includes working with cross-functional client teams on complex legal and regulatory issues related to drug development and post-marketing, including REMS evaluation and planning, FDA advisory board preparation, safety, promotional and scientific reviews. She is a frequent speaker and was a pharmacist prior to getting her law degree.
Dunne brings extensive experience in food and drug law, counseling companies regulated by the Food and Drug Administration on regulatory and compliance issues from pre-approval to post-launch with a focus on risk evaluation and mitigation strategies, labeling, advertising and promotional activities, reimbursement, good manufacturing practices, product recalls, and label warning letters. Debra provides guidance and legal counsel to her drug, medical device, food, dietary supplement, and cosmetics industry clients and has defended complex product-liability claims and has served as science and coordinating counsel in mass-tort litigation.
Debra is admitted to the Pennsylvania Bar and the U.S. District Court for the Eastern District of Pennsylvania, Dunne is also a member of the Food and Drug Law Institute. Debra received her J.D. from the Ohio Northern University Pettit College of Law and her B.S. from Duquesne University.
Articles in the National Law Review database by Debra Dunne