Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products

​Date & Time
July 11, 2024, 9:00 a.m.-5:00 p.m.
July 12, 2024, 9:00 a.m.-1:00 p.m.

​Event questions: mcersi@umd.edu

​Organized By
CDER Office of New Drugs, Division of Pediatrics and Maternal Health

​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. 

​Agenda

​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.

​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 before the meeting.

​Food & Drink
Coffee, beverages, light breakfast, crafted artisan salads and sandwiches will be available for purchase at the kiosk. The kiosk is the only accessible vendor to purchase food and beverage to non-FDA employees. Please note that the kiosk closes at 2pm, should you need an afternoon snack or beverage.

​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 and concerns, contact the FDAs CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov.