US FDA has not had a new drug application focused advisory committee meeting in more than two months, and none are currently scheduled in 2024. After a blistering pace in the first half of 2023, FDA’s sudden slowdown in expert panels is perplexing.
Drug sponsors are facing considerable uncertainty about the US Food & Drug Administration’s posture on advisory committees heading into 2024 after a wildly different set of experiences during the two halves of 2023.
The first half of the year saw a remarkable and dramatic change in the FDA’s use of advisory committee meetings,...
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.
