Kaveeta P. Vasisht M.D. Pharm.D. Dr. Kaveeta P. Vasisht is the Associate Commissioner for Women's Health and Director of the Office of Women's Health (OWH) at the US Food and Drug Administration (FDA). Under her leadership, FDA has advanced women's health through research, policy, scientific programming, education and outreach.
Dr. Vasisht has spearheaded the development of regulatory policy promoting the inclusion of women in clinical trials and the study of sex differences in the clinical evaluation of medical products to facilitate FDA regulatory decision making. In addition, she has led international harmonization and guideline development focused on good clinical practice and the inclusion of pregnant and breastfeeding women in clinical trials. Her work has also strengthened FDA's commitment to regulatory science by setting the women's health research priorities for the agency, expanding OWH's research portfolio and publishing the updated OWH Research Roadmap. Prior to joining OWH, she served as a Deputy Director in the Center for Drug Evaluation and Research Office of Medical Policy. Dr. Vasisht began her FDA career in the Office of New Drugs providing medical expertise in the evaluation of scientific data regarding risk-benefit assessments on the safety, effectiveness, and approvability of therapeutics in Division of Metabolism and Endocrine Products.
Dr. Vasisht has received numerous recognitions for her contributions to public health, including the FDA Commissioner's Special Recognition and Excellence Awards. She is also the recipient of the 2023 Health Public Service Visionary Award from the Society for Women's Health Research. Dr. Vasisht is double board-certified in internal medicine and adult endocrinology, diabetes, and metabolism, and holds a Doctor of Pharmacy degree. She completed her internal medicine training, clinical and research fellowship in adult endocrinology at the University of Chicago Hospitals, where she also served on the faculty. Dr. Vasisht has extensive clinical experience caring for patients with endocrine conditions and training fellows. She combines her medical, scientific, and regulatory expertise to further advance FDA's public health mission.
This presentation examines why early, sex-specific evidence generation is essential to advancing the health of women, and where gaps commonly arise in medical product development programs. It explores how thoughtful study design, and data integration can facilitate innovation throughout the product lifecycle. It also highlights FDA's Office of Women's Health's role in protecting and promoting women's health.
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