Optimizing Pregnancy Registries Public Workshop

Date: May 7 – 8, 2026 Day1: Thu, May 07 9:00 a.m. – 04:15 p.m. ET Day2: Fri, May 08 9:00 a.m. – 12:40 p.m. ET Location:

Event Location

Attend In Person or Online
Virtual: Link Coming Soon
In Person: FDA White Oak Campus
Building 31, Conference Center
The Great Room (Room 1503)

10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
United States

View Draft Agenda

Register Here

Summary

The Food and Drug Administration is announcing the public workshop, “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.

Objective

This 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 and approaches to optimize and improve pregnancy registries with key interested parties.

Topics for Discussion

• 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, health care 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 but not limited to disease based multi-product, multi-sponsor pregnancy registries and coordinated registry networks.

Visiting the FDA Campus

Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. All adults 18 and older will need to present REAL ID-compliant state-issued identification or other acceptable ID to enter FDA facilities. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

Virtual Attendance Information

This workshop will be hybrid. The link for virtual attendance will be provided to all registered attendees before the workshop.

Food & Drink

Refreshments are available for purchase. Campus lunch options are available by pre-order only. Attendees will be contacted prior to the workshop for lunch orders. Attendees may alternatively bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.

Accessibility

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email FDA’s Optimizing Pregnancy Registries Workshop Planning Team at OPRWorkshop@fda.hhs.gov at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Contact

For additional details, contact FDA’s Optimizing Pregnancy Registries Workshop Planning Team at OPRWorkshop@fda.hhs.gov.

• Content current as of:

  04/07/2026

Source