Notice2025-01164
Optimizing Pregnancy Registries; Public Workshop
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
January 17, 2025
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 workshop entitled "Optimizing Pregnancy Registries." The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation program.
Full Text
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<title>Federal Register, Volume 90 Issue 11 (Friday, January 17, 2025)</title>
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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5898-5899]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01164]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0001]
Optimizing Pregnancy Registries; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Optimizing
Pregnancy Registries.'' The purpose of the public workshop is to
discuss challenges in designing and implementing pregnancy registries
and to consider innovative approaches to improve the design and conduct
of pregnancy registries to inform the safety of drug and biological
products during pregnancy. This public workshop is being held in
collaboration with the University of Maryland Center of Excellence in
Regulatory Science and Innovation program.
DATES: The public workshop will be held on March 27, 2025, from 9 a.m.
to 4 p.m. eastern time and on March 28, 2025, from 9 a.m. to 12 p.m.
eastern time. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Room 1503), Silver Spring, MD 20993 and online. Entrance
for the 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: Denise Johnson-Lyles, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Silver Spring, MD 20993, 301-796-6169,
<a href="/cdn-cgi/l/email-protection#7837282a2f170a130b101708381e1c195610100b561f170e"><span class="__cf_email__" data-cfemail="521d0200053d2039213a3d22123436337c3a3a217c353d24">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Historically, pregnant individuals have been excluded from drug and
biological product development. At the time of initial approval of a
drug or biological product, there are generally limited data on the
safety of the product when used during pregnancy. Therefore,
postapproval pregnancy safety studies are needed to evaluate the safety
of a product in the postapproval setting and to inform safety-related
product labeling and clinical care.
Under the latest reauthorization of the Prescription Drug User Fee
Act, FDA made a commitment to develop a framework describing how to
optimally use data from different types of postapproval pregnancy
safety studies. On September 18-19, 2023, FDA and the Duke-Margolis
Institute for Health Policy convened a public workshop to discuss the
design of postapproval pregnancy safety studies for drug and biological
products.\1\ Participants and interested parties discussed ways these
studies can be optimized and different approaches that can be taken to
bridge knowledge gaps in developing the framework. Although data were
presented that suggest that pregnancy registry studies are an important
source of pregnancy safety information, interested parties noted
challenges with conducting single-drug, single-sponsor pregnancy
registries, including low enrollment and long lag time to study
completion. Similar to the Pregnant Women and Lactating Women
recommendations,\2\ interested parties identified the need to optimize
disease-
[[Page 5899]]
based multi-product, multi-sponsor pregnancy registries.
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\1\ <a href="https://healthpolicy.duke.edu/events/optimizing-use-postapproval-pregnancy-safety-studies">https://healthpolicy.duke.edu/events/optimizing-use-postapproval-pregnancy-safety-studies</a>.
\2\ <a href="https://www.nichd.nih.gov/about/advisory/PRGLAC">https://www.nichd.nih.gov/about/advisory/PRGLAC</a>.
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This current public workshop is part of FDA's commitment to advance
optimal approaches to efficient generation of high-quality human safety
data for drug products used during pregnancy. The purpose of the
workshop is to discuss current challenges in gathering safety data for
drug and biological products used during pregnancy and to discuss
approaches to optimize and improve pregnancy registries with key
interested parties.
II. Topics for Discussion at the Public Workshop
The objective of the meeting is to discuss the following topics
with interested parties:
<bullet> Current status of pregnancy registries and challenges in
gathering data regarding the safety of drug and biological products
used during pregnancy.
<bullet> Perspectives from interested parties (FDA, academia,
industry, healthcare providers, and patients) on strategies to improve
the design and conduct of pregnancy registries.
<bullet> Innovative approaches/models to facilitate the conduct of
pregnancy registries, including disease-based multi-product, multi-
sponsor pregnancy registries.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://lu.ma/bod9zouc">https://lu.ma/bod9zouc</a>. Persons interested in
attending this public workshop must register online by March 14, 2025,
11:59 p.m. eastern time. Please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone number.
Registration is free and based on space availability, with priority
given to early registrants. Registrants will receive confirmation when
they have been accepted. If time and space permit, onsite registration
on the day of the public workshop will be provided beginning at 8:30
a.m. eastern time. We will let registrants know if registration closes
before the day of the public workshop.
If you need special accommodations due to a disability, please
contact the Optimizing Pregnancy Registries Workshop Planning Team at
<a href="/cdn-cgi/l/email-protection#a9e6f9fbfec6dbc2dac1c6d9e9cfcdc887c1c1da87cec6df"><span class="__cf_email__" data-cfemail="eba4bbb9bc8499809883849bab8d8f8ac5838398c58c849d">[email protected]</span></a> no later than March 14, 2025.
Virtual Streaming 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/bod9zouc">https://lu.ma/bod9zouc</a>.
Although FDA verified the website addresses in this document, please
note that websites are subject to change over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a> (Docket No. FDA-2024-N-0001). It also may be viewed
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: January 10, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-01164 Filed 1-16-25; 8:45 am]
BILLING CODE 4164-01-P
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