Intro to COVID-19: Enforcement Action Guidelines, Legal Liabilities and Concerns
This session will address FDA’s enforcement discretion, including what it is an how it has been utilized by FDA during the COVID-19 health emergency. Ways to protect your company from liability considerations will also be discussed.
Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP
Angela M. Seaton, Partner, Shook, Hardy & Bacon LLP
This session was recorded as part of FDLI’s virtual course, “COVID-19: Introduction to FDA’s Existing Legal Authorities and Emerging Issues” on August 18, 2020.
SONALI P. GUNAWARDHANA is counsel at the law firm of Shook, Hardy & Bacon LLP in Washington, DC. She draws on her nearly 10 years’ experience as an attorney at FDA to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. Ms. Gunawardhana’s practice focuses on the rapidly changing FDA regulatory requirements for bringing pharmaceuticals and medical devices to market; the complex emerging rules applicable to domestic and foreign food manufacturers, suppliers, and importers; clinical trial compliance requirements for drug and medical device studies; and the defense of FDA enforcement actions against drug, device, food, cosmetic and dietary supplement companies. Ms. Gunawardhana received a BA from Syracuse University, a MA from Webster University, an MPH from Boston University, a JD from the University of New Hampshire School of Law and a LLM from Washington College of Law, American University.
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Legal issues regarding the response to COVID-19 is a rapidly evolving field. It is important to note the program recording date given that FDA guidance may have revised or been updated. For questions, please check the FDA website at: https://www.fda.gov/home
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