Advisory committee notes missing pieces in sponsor's data for abuse-deterrent oxycodone extended release opioid; excipients to deter abuse also need toxicity testing.
During an advisory committee review of its application for Rexista (oxycodone extended-release), Intellipharmaceutics International Inc. was unable to answer numerous questions about the safety and efficacy of the opioid, prompting panelists to question why the company had filed an application with limited data.
The committee's July 26 discussion provided a blueprint of sorts on what the company should do as it will likely...
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.
