The agency historically has had challenges recruiting experts for its advisory committees. With most everyone working from home during COVID-19, that task was just made easier, 3D Communications’ Jim DiBiasi says.
As the US Food and Drug Administration prepares for virtual advisory committee meetings, it is clear there are many obstacles to overcome – not the least of which are the technical challenges to an all-remote discussion.
But there is one potential upside: an easier time recruiting experts to participate. The FDA has struggled at times to...
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.
