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

Thursday, July 11, 2024
9:00 a.m.-5:00 p.m.
FDA White Oak Campus, Silver Spring Maryland
ONDPublicMTGSupport@fda.hhs.gov.

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

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. 

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
Please click here for the workshop agenda

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 InformationGetting 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
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.

Location
FDA White Oak Campus
10903 New Hampshire Ave, Silver Spring, MD 20903, USA
Building 31, Conference Center, The Great Room

 
Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science & Innovation, U01FD005946 totaling $30,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

remind we with google calendar

 

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