Meeting to address opioid abuse crisis was also a trial of whether FDA could conduct important public business using online-only technology.
At the conclusion of a US Food & Drug Administration advisory committee’s two-day review of “real world” data gauging the impact of Purdue Pharma L.P.’s reformulation of OxyContin on abuse and misuse of the opioid pain reliever, the lead FDA official at the meeting sounded unusually pleased with the outcome.
It is traditional for FDA to thank the committee members for their time and effort at the end of a...
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.
