Notice2024-11228
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products; Public Workshop
Primary source
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Published
May 22, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products." The purpose of the public workshop is to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant, understand the gaps in knowledge, and consider innovative approaches to improve collection of relevant data.
Full Text
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<title>Federal Register, Volume 89 Issue 100 (Wednesday, May 22, 2024)</title>
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[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44997-44998]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0001]
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug
and Biologic Products; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Evaluating Immunosuppressive
Effects of In Utero Exposure to Drug and Biologic Products.'' The
purpose of the public workshop is to discuss transplacental transfer of
drug and biological products with immunosuppressive properties and the
potential clinical impact on the developing fetus and newborn infant,
understand the gaps in knowledge, and consider innovative approaches to
improve collection of relevant data.
DATES: The public workshop will be held on July 11, 2024, from 9 a.m.
to 5 p.m. Eastern Time and on July 12, 2024, from 9 a.m. to 1 p.m.
Eastern Time. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus
and online. Entrance for the registered public workshop participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
FOR FURTHER INFORMATION CONTACT: Meshaun Payne and Michelle Pollack,
Office of New Drugs Public Meeting Support Team, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6466, Silver
Spring, MD 20993-0002, 301-796-6668, <a href="/cdn-cgi/l/email-protection#521d1c160227303e3b311f0615012722223d2026123436337c3a3a217c353d24"><span class="__cf_email__" data-cfemail="c58a8b8195b0a7a9aca688918296b0b5b5aab7b185a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Drug and biological products are widely used in various therapeutic
areas during pregnancy to treat various conditions. Some products can
be actively or passively transported across the placenta from a
pregnant individual to their fetus. When this occurs for products with
immunosuppressive properties, it is biologically plausible that these
products can exert immunosuppressive effects on the developing fetus
and newborn infant. Historically, pregnant individuals have generally
been excluded from clinical trials, resulting in a paucity of data
available on transplacental transfer and its potential consequences to
the developing fetus and newborn infant. This lack of data poses
challenges in providing adequate information in product labeling to
help prescribers and patients make informed decisions about use of
these products during pregnancy.
II. Topics for Discussion at the Public Workshop
Pregnant individuals may have chronic and/or acute conditions that
need to be treated, and published data show that most pregnant
individuals take at least one medication (excluding vitamins) during
pregnancy. Therefore, understanding the safety of medications when used
during pregnancy is important. The main objective of the ``Evaluating
Immunosuppressive Effects of In Utero Exposure to Drug and Biologic
Products'' workshop is to discuss the available data on the placental
transfer of drug and biological products with immunosuppressive effects
and the potential clinical impact on infants exposed in utero, identify
gaps in knowledge, and explore innovative and practical approaches for
collection of relevant data. In addition, the workshop will allow for
an open dialogue among regulators, academia, industry, and patient
organizations regarding the potential safety concerns of medicines that
may need to be used during pregnancy and approaches to data collection.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://lu.ma/5vdmbibm">https://lu.ma/5vdmbibm</a>. Please register by July 10,
2024, at 11:59 p.m. Eastern time. 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
workshop must register by July 10, 2024, at 11:59 p.m. Eastern time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted.
If you need special accommodations due to a disability, please
contact Brittany Witcher, OND Public Meeting Support Team at
<a href="/cdn-cgi/l/email-protection#83cccdc7d3f6e1efeae0ced7c4d0f6f3f3ecf1f7c3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="236c6d677356414f4a406e7764705653534c5157634547420d4b4b500d444c55">[email protected]</span></a> no later than July 1, 2024.
Streaming Webcast of the Public Workshop: This public workshop will
also be streamed virtually via Zoom. Virtual attendees may register at
the following website to receive the Zoom link: <a href="https://lu.ma/5vdmbibm">https://lu.ma/5vdmbibm</a>.
Although FDA verified the website addresses in this document, please
note that websites are subject to change over time.
Transcripts and Recordings: Please be advised that as soon as
transcripts and recordings of the public workshop are available, they
will be accessible on the FDA event web page https://www.fda.gov/drugs/
news-events-
[[Page 44998]]
human-drugs/evaluating-immunosuppressive-effects-utero-exposure-drug-
and-biologic-products-07112024. The transcripts and recordings will
also be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and may be viewed at
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11228 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P
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