Rules and Regulations. Notice of public workshop
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/register/2023/09/21/2023-20454·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6717-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2023-N-0001] Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration
(FDA)Office of Women's Health and Office of Clinical Pharmacology is announcing the following public workshop: “Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research.” The purpose of the public workshop is to 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. Researchers, educators, clinicians, and patients may benefit from attending this scientific workshop. Presentations will discuss whether changes in drug absorption, distribution, metabolism, and elimination, if any, could be affected by hormonal changes of menopause (independent of age), or other non-hormonal influences (including age-related renal and hepatic changes). The discussion is further intended to identify the research and data gaps regarding the potential impact of menopause on PK/PD. Speakers will highlight areas with the greatest need for further research and exploration. DATES: The public workshop will be held virtually on October 11, 2023, from 10 a.m. to 2 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held virtually using the Zoom platform. The link for the public workshop will be sent to registrants upon registration. FOR FURTHER INFORMATION CONTACT: Lisa Lineberger, Food and Drug Administration, Office of the Commissioner, Office of Women's Health, Bldg. 32, Rm. 2333, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8751, *OWHmeetings@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background Menopause is often a time of tremendous transition and change for women. The effects of menopause on the PK and PD of drugs are largely unknown. Sex hormone changes during menopause may affect the metabolic pathways of drugs by affecting drug metabolizing enzymes. Hormone changes may also affect other pathways that play an important role for drug disposition and excretion. In addition, many women experience weight gain at menopause. Together, these changes associated with menopausal transition have the potential to affect the PK of medications used for indications not related to menopause. Furthermore, physiologic changes in menopause may result in altered sensitivity to drug response independent of changes in PK. This public workshop will provide insight into identifying the research and data gaps regarding the potential impact of menopause on PK/PD, highlighting areas with the greatest need for further research and exploration. II. Topics for Discussion at the Public Workshop This public 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 session to respond to questions from attendees. III. Participating in the Public Workshop *Registration:* To register for the public workshop, please visit the following website: *https://www.fda.gov/consumers/public-meetings-workshops-and-webinars/menopause-potential-impact-clinical-pharmacology-and-opportunities-future-research-10112023.* Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Lisa Lineberger at *OWHmeetings@fda.hhs.gov* no later than October 10, 2023. Dated: September 18, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-20454 Filed 9-20-23; 8:45 am]