FDA News: Issue 6-2, June 2024

Author: [AUTHOR] Published on 6/7/2024 12:00:00 AM


FDA Announces Public Workshop on Evaluation of Immunosuppressive Effects of In Utero Exposure to Drugs and Biologic Products

On July 11 and 12, 2024, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) Division of Pediatrics and Maternal Health (DPMH) and the University of Maryland’s Center of Excellence and Regulatory Science (M-CERSI) will hold a co-sponsored workshop entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. The purpose of the 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. 

Workshop Objectives:


  • 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

Dates/Times of the Workshop:
Day 1: Thursday, July 11 9:00 AM - 5:00 PM ET
Day 2: Friday, July 12 9:00 AM - 1:00 PM ET

Meeting Information:
This workshop will be held both on-site at FDA’s White Oak Campus (Silver Spring, MD) and virtually. Registration is required for both online and on-site attendance.

For additional details, contact the FDA Office of New Drugs public meeting support team at ONDPublicMTGSupport@fda.hhs.gov.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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