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Biomarker-driven drug development for Allergic Diseases and Asthma—An FDA public workshop

The US Meals and Drug Administration (FDA) hosted a workshop on February 22, 2024, to debate the standing of biomarkers in drug growth for allergic bronchial asthma and meals allergy. The workshop supplied a discussion board for open dialogue amongst regulators, academicians, NIH workers and trade to tell stakeholders of the necessities for the FDA to undertake a biomarker as a surrogate endpoint for a medical trial, and to tell FDA of the standing of assorted biomarkers in growth. The workshop was divided into three periods: 1) FDA and EU regulators discussing regulatory views on use of biomarkers in drug growth applications; 2) investigators discussing biomarkers for pediatric and grownup bronchial asthma; and three) investigators discussing biomarkers for meals allergy.

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