The questions posed by the FDA to its Oncologic Drugs Advisory Committee for its most recent meeting all but answer themselves. The committee ultimately supported the agency’s negative view of the applications under review, but pushback during the meeting may encourage the agency to strike a more neutral tone in the future.
The US Food and Drug Administration’s questions prepared for outside advisors often raise concerns from committee members who want greater clarity or sharper definitions before voting on a difficult regulatory topic.
And then there are the questions prepared by the FDA for its Oncologic Drugs Advisory Committee meeting on 22 September:
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.
