Michele L. Buenafe

Associate

Michele L. Buenafe is an associate in Morgan Lewis's FDA and Healthcare Practice. Her practice focuses on FDA regulatory, compliance, and enforcement issues pertaining to medical devices and pharmaceuticals. As part of her practice, Ms. Buenafe regularly advises clients on issues related to the development, manufacturing, and marketing of medical devices, pharmaceuticals, biologics, and combination products; labeling and advertising; post-market requirements; and compliance with FDA's bioterrorism regulations. In addition, Ms. Buenafe has assisted clients in navigating the state regulatory requirements (including licensure requirements) applicable to drug and device manufacturers and distributors, pharmacies, DME suppliers, and healthcare providers. Ms. Buenafe also has experience advising clients on the regulatory requirements and emerging legal issues related to health information technology.

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.