Michele L. Buenafe

Associate

Michele L. Buenafe is an associate in Morgan Lewis's FDA/Healthcare Regulation Practice. Her practice focuses on FDA regulatory, compliance, and enforcement issues pertaining to pharmaceuticals and medical devices. As part of her practice, Ms. Buenafe regularly advises clients on issues related to the development, manufacturing, and marketing of medical devices, pharmaceuticals, biologics, combination products, labeling and advertising, pharmacovigilence activities, and compliance with FDA's bioterrorism regulations. In addition, Ms. Buenafe has assisted clients on issues related to federal and state regulation of healthcare providers, suppliers, and other entities.

Prior to joining Morgan Lewis, Ms. Buenafe worked at a consulting group, where she assisted on matters concerning pharmaceutical CGMP compliance.

Ms. Buenafe earned her J.D., high honors, from the George Washington University Law School in 2005. During law school, Ms. Buenafe served on the American Intellectual Property Law Association Quarterly Journal. In 1999, she earned her B.S. in chemical engineering from the University of Arizona.

Ms. Buenafe is admitted to practice in the District of Columbia and Maryland.