Cori Annapolen Goldberg

Cori focuses her practice on FDA and USDA regulatory issues for the food and beverage industry and on FDA regulatory issues for the drug, dietary supplement, biologic, medical device, and HCT/P industries across the supply chain. This includes PE funds and other companies investing in these industries, and academic medical centers and hospital systems utilizing FDA-regulated products. Cori advises both traditional medical device manufacturers and manufacturers of software products employing artificial intelligence (AI) and machine learning (ML) technologies. Cori has significant regulatory, transactional, and investigational experience.

Cori provides legal and strategic advice regarding communications with the FDA; assessments of products’ regulatory status; product labeling, advertising, and promotion; clinical research considerations across the product life cycle; and corporate compliance concerns. She assists clients during FDA inspections; in responding to FDA 483s, Untitled Letters, and Warning Letters; and with recalls and market withdrawals of products. Cori also advises product manufacturers, distributors, and retailers on FDA and state regulatory compliance considerations surrounding CBD products. In addition, Cori helps academic medical centers draft and negotiate master services agreements and trade agreements to bring groundbreaking cell and gene therapy products to their centers to help save the lives of their patients.