FDA advisory committee to consider proposed protocol to meet postmaketing requirement set a decade ago to determine risk of hyperalgesia following long-term use of ER/LA opioid analgesics. Initial trial was terminated in 2018 due to inability to recruit enough patients.
A decade after the US Food and Drug Administration required makers of extended-release and long-acting opioid analgesics to conduct a post-marketing study on the risk of opioid-induced hyperalgesia, manufacturers and the agency have a proposed protocol for review by its outside experts.
The agency’s Anesthetic and Analgesic Drug Products Advisory Committee will discuss the protocol at its 19 April meeting. In its...
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.
