Celeste Letourneau

Practice Areas

Celeste, a partner in Reed Smith’s Life Sciences Health Industry Group, advises clients on FDA and health care regulatory, compliance and enforcement matters. advises biologic and drug makers on FDA and health care regulatory, compliance, and enforcement matters across product life cycle. Celeste has particular experience in advising clients on FDA regulatory issues related to drug development strategy, planning, and conduct of Phase 1 through 4 clinical trials, marketing strategy, product approval, and post-marketing compliance.

In particular, Celeste has significant experience with helping clients to establish and manage large multicenter trials from start to data lock, including site selection, subject enrollment, contracting, payments to health care practitioners, and compensation to subjects. She also has extensive experience in FDA oversight of advertising and promotion to inform marketing strategy, and she participates on legal and medical review committees for advertising and promotional review of materials to ensure ongoing compliance with FDA and health care laws and regulations. Celeste also has significant experience with manufacturing and product quality matters.

Prior to beginning her legal career, Celeste was a registered nurse practicing in the areas of internal medicine, infectious diseases and oncology. As a registered nurse with experience in industry, Celeste has a strong understanding of the FDA and health care regulatory issues affecting biologic, pharmaceutical and medical device manufacturers and distributors.