Panelists at US FDA advisory committee on Inspirion's RoxyBond note reservations about abuse-deterrent claims absent more real-world data on how they work; FDA's Staffa suggests agency is eager to see how well premarket work predicts postmarket experience – though the data are far from being available.
Recent US FDA advisory committees have struggled with the lack of real-world data on how well abuse-deterrent opioids actually curtail abuse, but the most recent discussion underscores how the agency will look to postmarket studies to shape development requirements.
“I think we don’t know at all yet what these products are actually doing in the marketplace, but we are...
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.
