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.
Articles in the National Law Review database by Michele L. Buenafe