Notice2023-25816
Advancing Drug Development for the Prevention of Spontaneous Preterm Birth; Public Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 22, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Advancing Drug Development for the Prevention of Spontaneous Preterm Birth." The meeting will be convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, family, clinician, researcher, ethicist, professional society, and other stakeholder input on the impact of preterm birth on families and on society, as well as on the ethical, regulatory, and clinical trial considerations surrounding the drug development for the prevention of spontaneous preterm birth.
Full Text
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<title>Federal Register, Volume 88 Issue 224 (Wednesday, November 22, 2023)</title>
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[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Pages 81421-81422]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25816]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4996]
Advancing Drug Development for the Prevention of Spontaneous
Preterm Birth; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Advancing Drug
Development for the Prevention of Spontaneous Preterm Birth.'' The
meeting will be convened by Duke University's Robert J. Margolis, MD,
Center for Health Policy (Duke-Margolis) and supported by a cooperative
agreement with FDA. The meeting is intended to gather industry, family,
clinician, researcher, ethicist, professional society, and other
stakeholder input on the impact of preterm birth on families and on
society, as well as on the ethical, regulatory, and clinical trial
considerations surrounding the drug development for the prevention of
spontaneous preterm birth.
DATES: The public meeting will be held on January 23 and 24, 2024, from
1 p.m. to 4:30 p.m. Eastern Time each day. See the SUPPLEMENTARY
INFORMATION section for registration information.
ADDRESSES: The public meeting will be held virtually via Zoom.
FOR FURTHER INFORMATION CONTACT: Luke Durocher, Duke-Margolis Center
for Health Policy, <a href="/cdn-cgi/l/email-protection#462b273421292a2f352330232832350622332d2368232233"><span class="__cf_email__" data-cfemail="9df0fceffaf2f1f4eef8ebf8f3e9eeddf9e8f6f8b3f8f9e8">[email protected]</span></a>, 202-621-2800; or Christina
Chang, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-2078.
SUPPLEMENTARY INFORMATION:
I. Background Information
In the United States in 2021, 1 in every 10 infants was born
prematurely (before 37 weeks of pregnancy). Infants born too early have
higher rates of death and disability, resulting in a significant public
health concern. The exact mechanisms and risk factors associated with
spontaneous preterm birth are not fully understood, resulting in a
dearth of interventions demonstrated to be effective and safe.
FDA endorses an informed and balanced approach to gathering data
supporting the safe and effective use of drugs and biological products
for the prevention of spontaneous preterm birth. Currently, there is a
significant medical need for such therapies, as there are no FDA
approved therapies for reducing the risk of neonatal morbidity/
mortality resulting from spontaneous preterm birth. Input from this
meeting will help provide guidance on the development of therapies for
the prevention of spontaneous preterm birth.
II. Topics for Discussion at the Public Meeting
The meeting will allow participants (including clinicians,
patients, family, researchers, ethicists, professional societies, and
other stakeholders) to provide input on key topics, including:
<bullet> The current understanding of spontaneous preterm birth,
including the epidemiology of the condition, etiologies, and
pathophysiology
<bullet> Ethical and regulatory considerations and challenges
associated with the development of therapeutics for the prevention of
spontaneous preterm birth
<bullet> Impact of preterm birth on families and society
<bullet> Assessing efficacy and safety in clinical programs for
therapeutics for spontaneous preterm birth prevention
<bullet> Dose-finding and clinical trial design considerations
For more information on the meeting topics and discussion
questions, visit <a href="https://duke.is/g/gde6">https://duke.is/g/gde6</a>. Duke-Margolis will publish a
discussion guide outlining background information and current thinking
on the topic areas to this website approximately 2 weeks before the
meeting date. FDA will also post the agenda and other meeting materials
to this website approximately 5 business days before the meeting.
The format of the public meeting will consist of a series of
presentations, panel discussions, and open discussion.
III. Participating in the Public Meeting
Registration: To register for the virtual public meeting, please
visit the following website: <a href="https://duke.is/g/gde6">https://duke.is/g/gde6</a>. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
Registration is free. Persons interested in attending this virtual
public meeting must register. Early registration is recommended.
Registrants will receive confirmation once they have been accepted. If
you need special accommodations due to a disability, please contact
Luke Durocher, Duke-Margolis Center for Health Policy, at
<a href="/cdn-cgi/l/email-protection#731e1201141c1f1a001605161d070033170618165d161706"><span class="__cf_email__" data-cfemail="cea3afbca9a1a2a7bdabb8aba0babd8eaabba5abe0abaabb">[email protected]</span></a> or at 202-621-2800.
Streaming Webcast of the Public Meeting: This virtual public
meeting will be webcast via Zoom and the archived video footage will be
available at the event website. The link for registration is the same
as above: <a href="https://duke.is/g/gde6">https://duke.is/g/gde6</a>. Registered webcast participants will
be sent technical system requirements in advance of the event. It is
recommended that you review these technical system requirements prior
to joining the streaming webcast of the public meeting. Although FDA
has verified the website addresses in this document, please note that
websites are subject to change over time.
[[Page 81422]]
Transcripts: Please be advised that transcripts of the public
meeting will not be available.
Dated: November 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25816 Filed 11-21-23; 8:45 am]
BILLING CODE 4164-01-P
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