Gunawardhana Offers Insight on Complying with FDA Regulations

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.”