US FDA advisory committee will consider "noteworthy" imbalance in deaths in Paratek's trial in community-acquired bacterial pneumonia; agency could not determine cause, briefing documents note.
A mortality issue among patients in Paratek Pharmaceuticals Inc.'s trial of omadacycline in community acquired bacterial pneumonia could spark some discussion during what is otherwise likely to be a short advisory committee meeting for the product.
The US FDA was not able to determine a reason for the higher number of deaths in the omadacycline trial...
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.
