United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2023_register executive 2023-09-21 article Notices D09002ee1c79929d3 D09002ee1c7992a87 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 88 FR 65172 https://www.govinfo.gov/app/details/FR-2023-09-21/2023-20454 2023-20454 fr21se23-38 4164-01-P Docket No. FDA-2023-N-0001 https://www.govinfo.gov/app/details/FR-2023-09-21/2023-20454 https://www.govinfo.gov/content/pkg/FR-2023-09-21/html/2023-20454.htm https://www.govinfo.gov/content/pkg/FR-2023-09-21/pdf/2023-20454.pdf 2 p. 65172 65173 88 FR 65172 Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop; Federal Register Vol. 88, Issue NOTICE 2023-20454 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2023-N-0001 4164-01-P 2023-20454 Notice of public workshop.

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.

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. 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. Meetings: Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop, OWHmeetings@fda.hhs.gov https://www.fda.gov/consumers/public-meetings-workshops-and-webinars/menopause-potential-impact-clinical-pharmacology-and-opportunities-future-research-10112023 Vol. 88, no. 182 Office of the Federal Register, National Archives and Records Administration 2023-09-21 continuing daily deposited born digital 203 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2023-09-21 P0b002ee1c0ed438e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21se23 https://www.govinfo.gov/app/details/FR-2023-09-21 https://www.govinfo.gov/content/pkg/FR-2023-09-21/pdf/FR-2023-09-21.pdf https://www.govinfo.gov/content/pkg/FR-2023-09-21/xml/FR-2023-09-21.xml fdlp 65109 65304 DGPO 2023-09-21 2024-05-28 FR-2023-09-21 machine generated eng FR FR-2023-09-21 88 182