Sonali Gunawardhana

Shook Hardy & Bacon LLP

$ $$$

K Street Northwest 1800
Washington 20006 DC US

Sonali P. Gunawardhana draws on nearly ten years of 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.

She gives her clients the benefit of her deep knowledge of the law and a keen, forward-looking sense of how FDA may view a particular matter, giving the client the ability to develop the most effective and persuasive approach to any situation.

Her practice focuses on:

  • The rapidly changing FDA regulatory requirements for bringing medical devices and pharmaceuticals to market;
  • The complex emerging rules applicable to domestic and foreign food manufacturers, suppliers and importers;
  • Clinical trial compliance requirements for pharmaceutical and medical device studies; and
  • The defense of FDA enforcement actions against pharmaceutical, medical device, food, and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions and individual researchers.

Sonali counsels clients on regulation of medical devices; food and pet food regulation; pharmaceutical approvals; dietary supplements; and FDA enforcement defense. In addition to her experience at FDA, Sonali served as an attorney advisor at the U.S. Patent and Trademark office.

Before joining Shook, Sonali was of counsel for Wiley Rein LLP.

Representative Matters:

  • Counsels clients on the FDA regulatory system for the review and authorization of medical devices, drawing on her firsthand knowledge of the complexities and impacts of FDA’s informal and often unwritten policies and practices.
  • Counsels clients on the regulatory process, on how best to respond to enforcement actions, and strategies for submission of comments on proposed rulemaking.
  • Experienced in FDA regulation of medical devices, having served more than seven years at the Center for Devices and Radiological Health (CDRH) where she served as manager of the CDRH Application Integrity Policy Program (AIP) and as the integrity officer for the Division of Research Monitoring.
  • At CDRH, coordinated the review and approval of 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 the Institutional Review Boards; initiated enforcement recommendations with respect to advertising and promotional practices for marketed and investigational devices.
  • Works with food and pet food companies and associations on issues such as safety, nutrition and health, labeling, good manufacturing practice (GMP), packaging, biotechnology and the use of risk assessment and risk management in regulation of the safety of food components.
  • Served in FDA’s Center for Food Safety and Applied Nutrition, where she was immersed in numerous aspects of food safety policy and regulatory implementation related to the Food Safety Modernization Act (FSMA).
  • Assists clients with complex issues including the interpretation of the statutory definition of “dietary supplement,” the application of the “new dietary ingredient” criteria, permitted “structure” or “function” claims, and impermissible “disease” claims.
  • During her tenure with FDA, worked closely with the Office of Nutrition, Labeling, and Dietary Supplements to usher through the New Dietary Ingredients Draft Guidance under FSMA.
  • Counsels clients in strategies for the best course of action when regulatory correspondence is issued by FDA, based on her previous experience as Regulatory Counsel for the Division of Bioresearch Monitoring.
  • Worked closely with medical device companies and their counsel to address issues of noncompliance by submission of adequate corrective action plans.

Education:

  • LL.M., American University Washington College of Law, (2003)
  • J.D., University of New Hampshire School of Law, (1999)
  • M.P.H., Boston University, (1996)
  • M.A., Webster University, (1995)
  • B.A., Syracuse University, (1994)
  • Certificate in Business Administration, Georgetown University, (2011)

Bar Admissions:

  • District of Columbia
  • Maryland
  • New York
  • U.S. District Court, District of Maryland
  • U.S. Supreme Court

Memberships:

  • American Bar Association
    • Administrative Law & Regulatory Practice Section
  • Bloomberg/BNA
    • Medical Devices Law & Industry Report Advisory Committee
  • Food and Drug Law Institute
    • Food Enforcement and Compliance Conference Planning Committee (2019)
    • Medical Products Committee (2018-Present)
    • Medical Device Committee (2015-2018)
    • Global Committee (2013-2015)
    • Academic Programs Committee (2012-2015)
  • Maryland State Bar Association

Community Involvement:

  • Serves on the FDA Alumni Association Activities Committee (2017-Present)

Cost

Rate : $$$$

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K Street Northwest 1800
Washington 20006 DC US
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Lina Stillman

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Broadway 42
New York 10006 NY US
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