Cathy Burgess, partner in Alston & Bird’s Health Care Group and leader of the firm’s FDA Compliance & Enforcement Team, has been recognized by The National Law Journal in its third annual list of professionals identified as agents of change in health care and life sciences law.
Featured in the publication’s 2021 “Health Care | Life Science Trailblazers,” Burgess was recognized among a group of 29 lawyers described as “high profile honorees who are truly changing the landscape of healthcare law.”
Burgess was recognized in large part for advising clients on a wide range of Food and Drug Administration (FDA) matters related to the COVID-19 pandemic, including the development, manufacturing, and distribution of therapies, vaccines, personal protective equipment, test kits, and 3D-printed swabs. She advised clients on issues related to FDA emergency use authorizations for the distribution of convalescent plasma and redemsivir and new therapies for treating opportunistic infections brought on by the coronavirus. Also highlighted was Burgess’s work representing several drug manufacturers with products regulated under the Federal Food, Drug, and Cosmetic Act and guiding them in resolving disputes with the FDA over a previously undetected carcinogen in their products that led to global recalls.
Burgess has more than 25 years of experience advising clients on current good manufacturing practice (CGMP) regulation and supply chain management for prescription and over-the-counter drugs, biologics, medical devices, foods, and cosmetics. A member of Alston & Bird’s COVID-19 Response & Relief Team, Burgess is recognized as a leading practitioner by Chambers USA in pharmaceutical/medical products regulatory law and by Who’s Who Legal in life sciences.