US FDA Commissioner Califf has proposed that the agency move away from ‘gladiator votes’ that frame advisory committee meetings as a yes-or-no decision on a single question and instead emphasize the importance of the expert discussion and nuance of regulatory issues. The latest high-profile advisory committee review of a key opioid response issue shows the challenges with that approach.
US Food & Drug Administration officials routinely emphasize one key point in framing the questions they pose to their expert advisory committees: the agency values the discussion of the issues by the invited experts much more than the final count on any vote they may take.
Commissioner Robert Califf has urged that the agency apply that philosophy more directly, by holding more meetings that do not...
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.
