Document ID: FDA-2020-N-0001-0002
Agency: fda
Document Type: Notice
Title: Scientific and Ethical Considerations for the Inclusion of Pregnant Women in
Clinical Trials
Posted Date: 2020-03-11T04:00Z

[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14207-14208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04990]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0001]

Scientific and Ethical Considerations for the Inclusion of 
Pregnant Women in Clinical Trials

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 ``Scientific and 
Ethical Considerations for the Inclusion of Pregnant Women in Clinical 
Trials.'' The meeting will be convened by Duke University's Robert J. 
Margolis, Center for Health Policy (Duke-Margolis) and supported by a 
cooperative agreement with FDA. The meeting is intended to gather 
industry, patient, clinician,

[[Page 14208]]

researcher, institutional review board, ethicist, professional society 
and other stakeholder input on the scientific and ethical issues that 
surround the inclusion of pregnant women in clinical trials for drug 
development.

DATES: The public meeting will be held on April 16, 2020, from 9 a.m. 
to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration 
information.

ADDRESSES: The public meeting will be held at the National Press Club 
Main Ballroom, 529 14th St. NW, Washington, DC 20045.

FOR FURTHER INFORMATION CONTACT: Jasmine Smith, Office of New Drugs, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
at ONDPublicMTGSupport@fda.hhs.gov or 301-796-0621, or Catherine 
Sewell, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver 
Spring, MD 20993-0002, Fax: 301-796-9897.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA endorses an informed and balanced approach to gathering data 
informing the safe and effective use of drugs and biological products 
in pregnancy through judicious inclusion of pregnant women in clinical 
trials and careful attention to potential fetal risk. Input from this 
meeting will help provide such information on the development of 
therapies for pregnancy-specific conditions and for general medical 
conditions that occur in women of childbearing age and require 
treatment during pregnancy. This meeting supports the objectives of The 
Task Force on Research Specific to Pregnant Women and Lactating Women 
(``Task Force'' or ``PRGLAC'') which was established by section 2041 of 
the 21st Century Cures Act, Public Law 114-255, to provide advice and 
guidance on activities related to identifying and addressing gaps in 
knowledge and research on safe and effective therapies for pregnant 
women and lactating women, including the development of such therapies 
and the collaboration on and coordination of such activities.\1\ Input 
from this meeting may also help further inform FDA's work toward the 
finalization of the Agency's draft guidance: Pregnant Women: Scientific 
and Ethical Considerations for Inclusion in Clinical Trials (83 FR 
15161, April 6, 2018).
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    \1.\ https://www.nichd.nih.gov/sites/default/files/2018-09/PRGLAC_Report.pdf.
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II. Topics for Discussion at the Public Meeting

    The meeting will allow participants (including industry, 
clinicians, patients, researchers, institutional review boards, 
ethicists, professional societies and other stakeholders) to provide 
input on key topics, including:
     Key areas of unmet needs for therapeutic development or 
clinical data in obstetrics
     The regulatory, scientific, and ethical considerations and 
challenges in the enrollment of pregnant women in clinical research
    For more information on the meeting topics and discussion 
questions, visit https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. FDA 
will publish a discussion guide outlining background information 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 public meeting, please visit the 
following website: https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. 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. Persons interested in attending this public 
meeting must register. Early registration is recommended because 
seating is limited; therefore, FDA may limit the number of participants 
from each organization. Registrants will receive confirmation once they 
have been accepted. If time and space permit, onsite registration on 
the day of the public meeting will be provided beginning at 8 a.m. We 
will let registrants know if registration closes before the day of the 
public meeting.
    If you need special accommodations due to a disability, please 
contact Jasmine Smith, Office of New Drugs, Center for Drug Evaluation 
and Research, Food and Drug Administration, at 
ONDPublicMTGSupport@fda.hhs.gov or 301-796-0621; or Catherine Sewell, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver Spring, MD 20993-
0002, Fax: 301-796-9897.
    Persons attending FDA's meetings are advised that FDA is not 
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast and archived video footage will be available at the 
event website. If you are unable to attend the meeting in person, you 
can register to view a live webcast of the meeting. Persons interested 
in viewing the live webcast are encouraged to register in advance. You 
will be asked to indicate in your registration if you plan to attend in 
person or via the webcast. Please register for the webcast by visiting 
https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials.
    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.
    FDA has verified the website addresses in this document as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.
    Transcripts: Please be advised that transcripts of the public 
meeting will not be available.

    Dated: March 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04990 Filed 3-10-20; 8:45 am]
 BILLING CODE 4164-01-P