FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.
US Food and Drug Administration Commissioner Robert Califf wants advisory committees spending more time debating drug development topics that apply to multiple products, rather than the typical product-specific events.
Some top FDA career professionals championed the idea along with Califf, who endorsed it during the 13 February Prevision Policy/Friends...
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.
