US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact’

Expert panels may be used to help the FDA decide when and how a new biomarker could be leveraged for regulatory purposes. Participants at workshop on allergy and asthma biomarkers also discuss need for standardization of food allergy trials and new trial design approaches. 

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Advisory committees may help FDA decide the utility of biomarkers for allergy and asthma drug development programs • Source: Shutterstock

The US Food and Drug Administration will likely bring any promising biomarkers for allergy and asthma treatments to an advisory committee review before endorsing their use for regulatory purposes.

“If things have real impact, they would probably go before an advisory committee at some point,” Ronald Rabin, chief of the laboratory of immunobiochemistry in the Center for Biologics Evaluation and Research’s Office of Vaccines Research and Review, said at the conclusion of a recent all-day workshop on the development and use of biomarkers in the regulation of

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