Most FDA advisory committee members say potential mortality issue seen in community acquired bacterial pneumonia patients can be addressed postmarket.
A potential increase in mortality associated with Paratek Pharmaceuticals Inc.'s omadacycline in community-acquired bacterial pneumonia concerned many advisory committee members, but it was not enough to push them to vote that product safety had not been demonstrated.
Paratek is seeking approval for the tetracycline derivative in CABP as well as acute bacterial skin and skin structure infections...
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.
