US FDA advisory committee panelists argue that prospective, randomized Phase III trials fail to reflect real-world treatment decisions.
Members of a US FDA advisory panel opined that traditional Phase III studies are not sufficient to support opioid-sparing claims, and that Phase IV postmarketing studies are better equipped for such a purpose.
At a Nov. 15 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, several panelists specifically explained that prospective,...
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.
