Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research OCTOBER 11, 2023

https://www.fda.gov/consumers/public-meetings-workshops-and-webinars/menopause-potential-impact-clinical-pharmacology-and-opportunities-future-research-10112023?utm_medium=email&utm_source=govdelivery On October 11, 2023, the U.S. Food and Drug Administration (FDA) Office of Women’s Health (OWH), in collaboration with the Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP), will host a free virtual public workshop entitled Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research. This workshop will discuss the current understanding of the impact of menopause on drug pharmacology and highlight the areas with the greatest need for further research and exploration. This workshop will include presentations and session discussions by experts in the fields of clinical pharmacology, obstetrics and gynecology, endocrinology, and clinical care. Each session will include a Q&A to respond to questions from attendees. Speakers will discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA-regulated drugs and biologics used by menopausal women for non-menopause-related indications. The discussion is intended to identify the research and data gaps regarding the potential impact of menopause on PK/PD. Workshop Objectives: Examine the biological and physiological changes that occur during menopause Discuss the current understanding of the impact of menopause on the PK, PD, and exposure-response relationships of FDA-regulated products used by menopausal women for non-menopause-related indications Discuss whether the changes in drug absorption, distribution, metabolism, and elimination, if any, are specifically due to hormonal changes of menopause (independent of age), or other non-hormonal influences (including age-related renal and hepatic changes) Identify the research and data gaps regarding the impact of menopause on PK/PD, highlighting areas with the greatest need for further research and exploration Date/Time of the Workshop: Date: October 11, 2023 Time: 10:00 am-2:00 pm ET