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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

Meeting Recordings

Day 1 - July 11, 2024

Watch on YouTube

Day 2 - July 12, 2024

Watch on YouTube

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 - 245 KB)

Contact

For additional details, contact the FDAs CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov.

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