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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 [www.gpo.gov]
[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 https://www.fda.gov/about-fda/visitor-information.

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, 
[email protected].

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\ https://healthpolicy.duke.edu/events/optimizing-use-postapproval-pregnancy-safety-studies.
    \2\ https://www.nichd.nih.gov/about/advisory/PRGLAC.
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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:
     Current status of pregnancy registries and challenges in 
gathering data regarding the safety of drug and biological products 
used during pregnancy.
     Perspectives from interested parties (FDA, academia, 
industry, healthcare providers, and patients) on strategies to improve 
the design and conduct of pregnancy registries.
     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: https://lu.ma/bod9zouc. 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 
[email protected] 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: https://lu.ma/bod9zouc. 
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 https://www.regulations.gov (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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