Risk committee has joined nearly all opioid reviews over past few years but didn’t for AcelRx's sublingual product; Raeford Brown, the analgesic advisory committee chair who was unable to attend the meeting, voices his displeasure with the vote.
AcelRx Pharmaceuticals Inc.'s sublingual opioid Dsuvia (sufentanil) made waves by becoming the first opioid in 2018 to get a positive vote from a US FDA advisory committee. But Public Citizen is alleging that agency deliberately decided not to convene the full Drug Safety and Risk Management Advisory Committee (DSRMAC) to help deliver a positive vote.
In a letter dated Oct. 18 sent to FDA Commissioner Scott Gottlieb, Center for Drug Evaluation and Research (CDER)...
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.
