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.