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Former FDA Counsel Joins Wiley Rein

Sonali P. Gunawardhana Brings Extensive Medical Device and Food Safety Experience to Firm's Food & Drug Practice

September 4, 2012

Wiley Rein LLP announced today that Sonali P. Gunawardhana, formerly with the U.S. Food and Drug Administration (FDA), has joined the firm’s Food & Drug Law Practice as of counsel. Ms. Gunawardhana brings to the firm extensive regulatory and compliance experience in the areas of medical devices and food safety. 

“We are delighted to have someone of Sonali’s stature on board,” said Chairman Richard E. Wiley. “Her arrival strengthens and broadens our impressive roster of FDA attorneys, particularly in the areas of medical devices and food safety.” James N. Czaban, Chair of the firm’s Food & Drug Law Practice Group, added, “Sonali’s skill set, contacts and in-depth expertise in medical devices and food safety will make her a unique and valuable resource to our existing clients, and to companies looking for a fresh perspective on their FDA regulatory matters.”

Ms. Gunawardhana served nearly a decade at FDA—including seven years at the Center for Devices and Radiological Health (CDRH)—and more recently in the Center for Food Safety and Applied Nutrition (CFSAN). During her tenure at FDA, she also served several temporary duty assignments in the Center for Drug Evaluation and Research (CDER), including in the Office of Compliance and the Office of Medical Policy.  

Among her many roles at CDRH, Ms. Gunawardhana served as the Center’s Integrity Officer and as manager of the Application Integrity Policy (AIP) Program. In these roles she handled all application integrity issues for pre-market devices (for the Office of Device Evaluation and for the Office of In Vitro Diagnostics)and for marketed devices for the Office of Surveillance and Biometrics. She coordinated the review and approval of CDRH Guidance documents; exercised supervisory review of all proposed Warning Letters, Untitled Letters and AIP enforcement actions against medical device sponsors, clinical investigators, good clinical laboratories and Institutional Review Boards; and initiated enforcement recommendations with respect to advertising and promotional practices for marketed and investigational devices. She also handledCurrent Good Manufacturing Practice (cGMP) and labeling compliance issues.

While at CFSAN Ms. Gunawardhana was immersed in numerous aspects of food safety policy and regulatory implementation related to the recently enacted Food Safety Modernization Act (FSMA).  She served as the lead regulatory counsel and regulation writer on both the Sanitary Food Transportation Act Proposed Rule and the Product Tracing Proposed Rule as required by FSMA.

Early in her career, Ms. Gunawardhana served for two years as an Attorney Advisor/Trademark Examiner at the U.S. Patent and Trademark Office (PTO).

At Wiley Rein, Ms. Gunawardhana will counsel clients on the development of medical device and clinical trial regulatory strategies, food safety, hazard analysis and preventative control measures, pharmaceutical approval and marketing issues and a broad range of regulatory enforcement matters.  “I am thrilled to join such a well-respected firm with a deep history of service to FDA-regulated clients,” she stated, “and I look forward to working with lawyers from Wiley Rein’s diverse group of relevant practice areas.” 

Ms. Gunawardhana has a J.D. with a concentration in Health Law from the University of New Hampshire School of Law, an LL.M. with a concentration in Intellectual Property Law from American University’s Washington College of Law and a Master of Public Health (M.P.H.) degree with double concentrations in Health Services & Health Law,from Boston University.  Ms. Gunawardhana earned her B.A. from Syracuse University.

Wiley Rein's Food & Drug Law Practice dates to the founding of the firm in 1983 and its attorneys have decades of experience advising FDA-regulated companies on a variety of legal and regulatory challenges in the pharmaceutical, biotechnology, medical device, food and dietary supplement industries.  Its partners have held high-ranking positions in government and the team includes such luminaries as Bert W. Rein—who was named both a Washington “Visionary” and a “Leading Lawyer in Food and Drug Law” by The National Law Journal—and Mr. Czaban, who has been recognized as a leading Food & Drug lawyer on such local, national and international lists as Chambers USA, PLC Which lawyer?, Washingtonian, Best Lawyers and Lawdragon.