Intro to COVID-19: Defining Emergency Use Authorization (EUA) Authorities
This session will address general regulatory requirements for bringing a medical product to market under emergency use authorities in the Federal Food, Drug, and Cosmetic Act.
Cathy L. Burgess, Partner, Alston & Bird LLP, Member, FDLI Board of Directors
This session was recorded as part of FDLI’s virtual course, “COVID-19: Introduction to FDA’s Existing Legal Authorities and Emerging Issues” in August 2020.
CATHY L. BURGESS is a partner at the law firm of Alston & Bird, LLP in Washington, DC, and serves as the co-chair of the firm’s FDA Practice. Her practice focuses primarily on regulatory compliance, product and supply chain risk management, enforcement, and policy matters related to CGMP and QSR regulation of global manufacturers. Ms. Burgess provides strategic counseling, conducts internal investigations and special audits related to FDA compliance, and assists clients in designing compliance programs, internal audit programs, and other risk mitigation strategies. She is recognized as a leading practitioner for life sciences, food and beverage law, and in the area of pharmaceutical and medical products regulation.Get Access
$99
- +$100 for nonmembers
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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