Agency officials are considering developing policies for when an advisory committee meeting is appropriate, in part because of the workload associated with them. Could fewer meetings result?
The US Food and Drug Administration’s advisory committee scheduling policy could be updated as part of an ongoing modernization initiative, potentially impacting the number of meetings that could be held.
Kevin Bugin, acting deputy director of operations in the FDA Office of New Drugs, said that because 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.
