Suzanne O'Shea is a Director in Guidehouse's FDA Regulatory practice. Her areas of expertise include strategic analysis of regulatory pathways depending on unique client circumstances in evolving areas of regulation such as combination products, laboratory developed tests, and Section 361 status of human tissue products. She also advises clients in the areas of informed consent, investigator disqualification proceedings, Form 483/Warning Letter responses, quality agreements, good manufacturing practices for combination products, and review of promotional materials for products of all types. Additionally, she serves as an expert witness on FDA processes.
Suzanne has more than three decades of regulatory strategy and compliance experience in the Life Sciences industry in roles at the U.S. Food and Drug Administration (“FDA”) headquarters in Rockville, Maryland, and in private legal practice. She is frequently called upon by clients to assist in navigating FDA regulations affecting combination products, pharmaceutical products, human cells and tissue products, and medical devices.
Suzanne served as Regulatory Counsel at FDA for 21 years, in the Center for Drug Evaluation and Research, the Office of the Chief Mediator and Ombudsman, and the Office of Combination Products. She served as a non-voting member of the Tissue Reference Group for many years.
Holder of an LL.M. from George Washington University School of Law and a J.D. from Indiana University Maurer School of Law, Suzanne is a frequently invited speaker and has published widely.
LL.M., Administrative Law, National Law Center, George Washington University J.D. Indiana University Maurer School of Law