Cori Goldberg, a partner in our Life Sciences Health Industry Group, focuses her practice on FDA regulatory issues for the food, drug, and medical device industries; health law matters; government and internal investigations; and white collar criminal defense. Cori has regulatory, investigational, and transactional expertise.
She works with clients including medical device manufacturers, pharmaceutical companies, food manufacturers, health care PE firms, hospitals, academic medical centers, physicians, and other health care providers.
Cori advises her clients on food and drug law issues, including labeling analysis, FSMA implementation, and food safety concerns; clinical research considerations; and corporate compliance concerns. She assists clients during FDA inspections, in responding to FDA 483s, and with recalls of products.
Her practice includes the representation of clients during internal investigations and self-disclosures. She also represents large corporations in investigations by the US Department of Justice, the US Food and Drug Administration, US Department of Health and Human Services Office of Inspector General, and other federal and state agencies.
Prior to joining, Cori served as a judicial law clerk to Judge Clayton Greene, Jr. on the Court of Appeals of Maryland.
- 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
- New York
Professional Affiliations :
- New York State Bar Association – Food, Drug & Cosmetic Law Section
- Member, Committee on Food Law
- National Association of Women Lawyers (NAWL)
- Member, Women in Compliance Practice Area Affinity Group
- Healthcare Businesswomen’s Association
- Mid-Atlantic Executive Board of Directors, President-Elect (2012)
- American Health Lawyers’ Association
- Assists food manufacturers with FSMA registration and implementation, Nutrition Fact Panel labeling requirements, and GMO labeling requirements
- Drafts healthcare and FDA representations and warranties for device, drug, food and PE clients in M&A transactions
- Represented an orthopedic device company in its $375 million sale to a global medical technology company in its FDA regulatory matters
- Advises medical device companies about FDA reporting obligations under 21 C.F.R. Part 806
- Advises clients about financial conflicts-of-interest issues, IRB requirements, fraud and abuse issues, and other compliance issues in clinical trials
- Advises medical device companies about the provision of consulting services including pre-authorization services, coding advice, and other reimbursement assistance
Rate : $$$