PRESS RELEASE
10 March 2020

Gunawardhana Offers Insight On Complying With FDA Regulations

SH
Shook, Hardy & Bacon

Contributor

Shook, Hardy & Bacon has long been recognized as one of the premier litigation firms in the country. For more than a century, the firm has defended companies in their most substantial national and international products liability, mass tort and complex litigation matters.

The firm has leveraged its complex product liability litigation expertise to expand into several other practice areas and advance its mission of “being the best in the world at providing creative and practical solutions at unsurpassed value.” As a result, the firm has built nationally recognized practices in areas such as intellectual property, environmental and toxic tort, employment litigation, commercial litigation, government enforcement and compliance, and public policy.

Shook Of Counsel Sonali Gunawardhana has participated in a Corporate Disputes roundtable on compliance with regulations promulgated by the U.S. Food and Drug Administration (FDA).
United States

Shook Of Counsel Sonali Gunawardhana has participated in a Corporate Disputes roundtable on compliance with regulations promulgated by the U.S. Food and Drug Administration (FDA). Gunawardhana offered answers on building strategic processes for compliance, trends in FDA regulatory efforts and more.

"The FDA tends to be consistent in its approach when it comes to enforcement actions, regardless of a new administration, but the priorities may shift based on the new administration's goals," Gunawardhana explains. "As many of the enforcement activities span over the lifecycle of products, the agency tends to be consistent in its approach. As we are dealing with a global economy, we believe that the FDA will look to further partner with other international regulatory authorities in order to protect the nation's public health."

Contributor

Shook, Hardy & Bacon has long been recognized as one of the premier litigation firms in the country. For more than a century, the firm has defended companies in their most substantial national and international products liability, mass tort and complex litigation matters.

The firm has leveraged its complex product liability litigation expertise to expand into several other practice areas and advance its mission of “being the best in the world at providing creative and practical solutions at unsurpassed value.” As a result, the firm has built nationally recognized practices in areas such as intellectual property, environmental and toxic tort, employment litigation, commercial litigation, government enforcement and compliance, and public policy.

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