Cori, a partner in our Life Sciences Health Industry Group, focuses her practice on FDA regulatory issues for the food, drug, dietary supplement, biologic, medical device, and HCT/P industries across the supply chain, including companies investing in these industries. Cori has regulatory, transactional, and investigational expertise.
Cori specializes in providing legal and strategic advice regarding communications with FDA; pre-submission meeting requests and product approval submissions to FDA; 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 and Warning Letters, and with recalls and market withdrawals of products. With the passage of the 2018 Farm Bill, Cori has advised product manufacturers, distributors, and retailers on FDA regulatory compliance considerations surrounding CBD products.
Qualifikationen
Auszeichnungen
- Ranked in Chambers USA for New York Healthcare, 2024
- Ranked in Chambers USA for Nationwide Food & Beverages: Regulatory & Litigation, 2023-2024
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Rising Star, NY Metro Super Lawyers - Food & Drugs, Thomson Reuters, 2016
- Rising Star, Healthcare Businesswomen's Association, 2011
Notable quotes
- 2023 February 2 "FDA Will Not Regulate CBD, Asks Congress To Act," Forbes