Cathy Burgess

Partner
Alston & Bird
 

Cathy Burgess leads Alston & Bird’s FDA compliance and enforcement team and co-leads the firm’s FDA practice. Burgess advises clients on a range of matters affecting prescription and OTC drugs, biologics, medical devices, foods, and cosmetics. She has extensive experience regarding current good manufacturing practice regulation and supply chain management. Burgess conducts liability risk assessments and works with clients to identify and analyze potential legal risks associated with their products. She advises clients on quality systems, adequacy of SOPs, investigation reports, inspection management, recalls, and responses to Form FDA 483s and warning letters.

 

Sessions: 

Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site