Tracey Zoetis, MS

Tracey serves as a scientific and regulatory strategic expert for a variety of product development programs. Tracey specializes in evaluating the toxicological properties of pharmaceuticals, biologics, and medical devices. She is recognized for her experience in developing drugs using specialized routes of administration and novel technologies. Tracey is also experienced in developing testing strategies appropriate to test compounds in special populations. As a former Study Director, she has designed and conducted hundreds of toxicity and carcinogenicity studies, in a variety of laboratory species, using most recognized routes of administration. Tracey is a former reviewer in the FDA Center of Drug Evaluation and Research Divisions of Pulmonary and Allergy Drug Products and Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products and internal consultant to the FDA Centers for Devices and Radiological Health and Food Safety and Nutrition. In addition to her responsibilities as a Reviewer, Tracey served on several internal FDA committees and working groups, addressing issues such as carcinogenicity testing strategy and interpretation, pharmacokinetics instruction for reviewers, the use of inactive ingredients in pharmaceutical products, and testing strategies to support pediatric safety. She is co-editor of the book Direct Dosing of Pre-Weaning Mammals in Toxicity Testing, as well as a series of articles on the comparative postnatal development of selected organ systems. Tracey is President-Elect of the American College of Toxicology. She has an M.S. in Environmental Science from George Washington University.