Cathy L. Burgess Alston & Bird, LLP

Cathy Burgess is a distinguished professional with over 30 years of expertise in guiding FDA-regulated entities toward achieving business objectives while mitigating compliance and enforcement risks. As the leader of the FDA Compliance and Enforcement Team at Alston & Bird, Cathy provides strategic counsel to clients, specializing in CGMP regulation and product risk management.In her role, Cathy collaborates with clients to identify and address potential risks throughout the product life cycle. Her extensive experience encompasses prescription and OTC drugs, biologics, medical devices, foods, cosmetics, and current good manufacturing practice (CGMP) regulation.As a Partner, Cathy has a proven track record of advising on a spectrum of matters, including liability risk assessments, quality system remediation, inspection management, recalls, and responses to Form FDA 483s and warning letters. She is recognized as a leading practitioner for life sciences, ranked in The Best Lawyers in America© in FDA and Food and Beverage Law, and holds a prominent position in Chambers USA in Pharmaceutical/Medical Products Regulatory.Cathy's role at Alston & Bird follows her tenure as Associate General Counsel for the American Red Cross, where she oversaw regulatory matters. She has a history of successful negotiations, including resolving import alerts, warning letters, and FDA consent decrees. Her expertise extends to pandemic-related counseling, regulatory due diligence, and providing guidance on compliance obligations surrounding the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).Cathy is a thought leader in the industry, as evidenced by her numerous publications and presentations on topics such as CGMPs, data integrity, and FDA compliance. She has received recognition for her contributions, including the FDLI 2023 Distinguished Service and Leadership Award.Cathy Burgess is a member of the Food and Drug Law Institute's board of directors and has chaired various committees, demonstrating her commitment to professional and community engagement. She is admitted to practice in the District of Columbia and holds a Juris Doctor from The Catholic University of America.For unparalleled expertise in navigating FDA regulations and ensuring compliance, Cathy Burgess stands out as a trusted and accomplished partner in the pharmaceutical and life sciences industries.