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 FDA; pre-submission meeting requests and product approval submissions to 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.
Experience
Representative matters
Recognitions
- Ranked in Chambers USA for New York Healthcare, 2024-2025
- Ranked in Chambers USA for Nationwide Food & Beverages: Regulatory & Litigation, 2023-2025
- Selected as a NY Metro Super Lawyers Rising Star for Food & Drugs, Thomson Reuters, 2016
Credentials
Education
- University of Maryland School of Law, 2006, J.D., cum laude
- University of Maryland School of Medicine, 2006, M.P.H.
- Emory University, 2003, B.A.
Professional admissions & qualifications
- District of Columbia
- Maryland
- New York
Professional affiliations
- The Leptomeningeal Cancer Foundation, Board Member and Secretary
- Life Sciences Advisory Board for Lexis Practical Guidance, Board Member
- Retail & Consumer Goods Team, Chair of Food & Beverage Sub-Group
- New York Recruiting Committee of Reed Smith, Co-Hiring Partner
- Women’s Initiative Network of Reed Smith, New York Chairperson
- New York State Bar Association
- Food, Drug & Cosmetic Law Section – Member, Committee on Food Law, 2018-2022
- Member, Committee on Cannabis Law, 2019-2022
- Healthcare Businesswomen’s Association
- Mid-Atlantic Executive Board of Directors, President-Elect, 2012
- Mid-Atlantic Board of Directors, Director-at-Large, Programming, 2011
- Mid-Atlantic Chapter, Event Coordinator, 2010
Clerkships
- State Supreme Court - Maryland, Honorable Clayton Greene, Jr.