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  4. Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products - 07/11/2024
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Event Title
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
July 11 - 12, 2024


Date:
July 11 - 12, 2024
Day1:
- ET
Day2:
- ET


Workshop Location

FDA White Oak Campus
Building 31, Conference Center, The Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993

Organized By

CDER Office of New Drugs, Division of Pediatrics and Maternal Health
M-CERSI

Summary

The Food and Drug Administration (FDA, the Agency, or we) 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.

Topics for Discussion

The main objectives of the “Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products” workshop are to:

  • Discuss the available data on the placental transfer of drug and biological products with immunosuppressive effects.
  • Discuss the potential clinical impact on infants exposed in utero.
  • Identify gaps in knowledge.
  • Explore innovative and practical approaches for collection of relevant data.
  • Allow an open dialogue amongst regulators, academia, industry, and patient organizations regarding the potential safety concerns and approaches to data collection.

About The Co-Sponsor

M-CERSI is an FDA-sponsored center at the Baltimore and College Park campuses of the University of Maryland, under the coordination of FDA Office of Regulatory Science and Innovation (ORSI). The mission of the center is to foster the development of regulatory science—the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

Agenda

Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products - Agenda (PDF - 252 KB)

Visiting the FDA Campus (If held at FDA Campus)

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 Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

Virtual Attendance Information

This meeting will be hybrid. The Zoom link will be provided to all registered attendees in a calendar invite the before the meeting.

Food & Drink

Refreshments and sandwiches are available for purchase. Attendees may 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 ONDPublicMTGSupport@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 the FDAs CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov.

 
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