US FDA was hoping Pulmonary-Allergy Drugs Advisory Committee could help provide some clarity on its use, but there still are many questions.
The usefulness of blood eosinophil count as a biomarker may still need clarification following trials using GlaxoSmithKline PLC's Nucala (mepolizumab) in COPD, despite the US FDA's hopes to the contrary.
Members of the Pulmonary-Allergy Drugs Advisory Committee seemed befuddled by many of the questions FDA raised, including what eosinophil count...
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.
