[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65172-65173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20454]


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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.

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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, <a href="/cdn-cgi/l/email-protection#c18e9689aca4a4b5a8afa6b281a7a5a0efa9a9b2efa6aeb7"><span class="__cf_email__" data-cfemail="e0afb7a88d858594898e8793a0868481ce888893ce878f96">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

[[Page 65173]]

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 <a href="/cdn-cgi/l/email-protection#89c6dec1e4ececfde0e7eefac9efede8a7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="d39c849bbeb6b6a7babdb4a093b5b7b2fdbbbba0fdb4bca5">[email protected]</span></a> 
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]
BILLING CODE 4164-01-P


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