Linda Epstein
Associate Chief Counsel at FDA
- Role
- Associate Chief Counsel at FDA
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Linda Epstein
Seasoned regulatory attorney specializing in pharmaceutical and tobacco law. Expert in…
Experience
Associate Chief Counsel
Jan 2011 — Present
Interpret the Food, Drug, and Cosmetic Act and other relevant statutes, regulations, and policies to provide legal advice and counsel to the Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Tobacco Products. • Draft legal memoranda and help develop regulations and guidance documents for various businesses and others regarding Food, Drug, and Cosmetic Act compliance. • Provide subject matter expertise in Risk Evaluation and Mitigation Strategies (REMS), drug safety, registration and listing, labeling, advertising and promotion, and cigarette health warnings, premarket tobacco product applications, and development of tobacco product standards.• Co-leader for cross-cutting team overseeing projects involving relationships with parties outside the FDA, such as public-private partnerships. Advise on memoranda of understanding, grants, and cooperative agreements. • Edit and review official communications, including press statements, to businesses and others regarding compliance issues and new initiatives.
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