2025-01164. Optimizing Pregnancy Registries; Public Workshop

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2024-N-0001]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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, [e-mail].

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- ( print page 5899) based multi-product, multi-sponsor pregnancy registries.

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 [e-mail] 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.

Footnotes

1.   https://healthpolicy.duke.edu/​events/​optimizing-use-postapproval-pregnancy-safety-studies.

2.   https://www.nichd.nih.gov/​about/​advisory/​PRGLAC.