Biomarker-driven drug development for allergic diseases and asthma: An FDA public workshop.
other · Level V
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- Record sourced from PubMed, PMID 40154576.
- Also identified by DOI 10.1016/j.jaci.2025.03.014 and PMC identifier 12145241.
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Abstract
The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, National Institutes of Health staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate end point for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into 3 sessions: (1) FDA and European Union regulators discussing regulatory perspectives on use of biomarkers in drug development programs, (2) investigators discussing biomarkers for pediatric and adult asthma, and (3) investigators discussing biomarkers for food allergy. In this report, we review the information presented at the workshop and summarize the current status of potential biomarkers for these allergic diseases.
Medical subject headings
- Asthma
- Biomarkers
- Drug Development
- Food Hypersensitivity
- Hypersensitivity