Sonali P. Gunawardhana Esq.

Wiley Rein LLP
Gunawardhana, Sonali P.

Sonali P. Gunawardhana is Of Counsel at , where she draws on her nearly 10 years’ experience as an attorney at the U.S. Food and Drug Administration (FDA) to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges, and serves as a member of the advisory board of Law's Medical Devices Law & Industry Report.

Ms. Gunawardhana’s practice focuses on the rapidly changing FDA regulatory requirements for bringing medical devices to market; the complex emerging rules applicable to domestic and foreign food manufacturers, suppliers, and importers; clinical trial compliance requirements for drug and medical device studies; and the defense of FDA enforcement actions against drug, device, food, and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions, and individual researchers.

Ms. Gunawardhana served as Acting Supervisory Regulatory Counsel at the FDA's Center for Food Safety and Applied Nutrition, Office of Regulations and as Regulatory Counsel/Integrity Officer at the FDA's Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring. She was previously an Attorney Adviser at the U.S. Patent and Trademark Office.

She earned her B.A. from Syracuse University, her M.A. from Webster University, an M.P.H. from Boston University, a J.D. from the University of New Hampshire School of Law and an LL.M. from the American University Washington College of Law.

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