So far this year, when the agency has taken action on NMEs that went before advisory committees, the FDA decision has matched the committee vote.
The US FDA convened five advisory committee meetings to discuss NMEs and novel biologics during the first half of the year. Two of the meetings took place after the user fee goal date had passed, suggesting the value that the FDA places on scientific advice for challenging applications.
While the agency is not bound by the recommendations of its advisory committees, it does consistently agree with them. Indeed,...
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.
