Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop
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Abstract
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.
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<title>Federal Register, Volume 88 Issue 182 (Thursday, September 21, 2023)</title>
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[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65172-65173]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.fda.gov/consumers/public-meetings-workshops-and-webinars/menopause-potential-impact-clinical-pharmacology-and-opportunities-future-research-10112023">https://www.fda.gov/consumers/public-meetings-workshops-and-webinars/menopause-potential-impact-clinical-pharmacology-and-opportunities-future-research-10112023</a>. 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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