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.
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...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
