In unusual public hearing, Edwin Thompson, head of the US firm that contract manufactures Endo’s long-acting opioid, tells US FDA advisory committee that intranasal ‘liking’ study violated FDA requirements. Thompson has petitioned the agency to do away with need for human abuse liability studies entirely, asserting they are inherently flawed.
The open public hearing at FDA advisory committee meetings on opioids always engenders strong and passionate opinions, with survivors of opioid overdose victims seeking strict limits on the drugs’ prescribing or market withdrawal while chronic pain patients plead for continued access to help them manage the severity of their conditions.
These voices were heard at the Drug Safety and Risk Management and the Anesthetic and Analgesic Drug Products panels’ recent...
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.
