US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.
US Food and Drug Administration advisors’ general lack of confidence in risk evaluation and mitigation strategies ability to lessen safety concerns with drugs appeared to be a significant factor in the negative panel vote on 2 November against Charleston Laboratories, Inc.’s opioid combo Hydexor.
The Anesthetics and Analgesic Drugs Products Advisory Committee and Drug Safety and Risk Management Advisory Committee members who voted against...
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.
