Advisory committee will review applications for cUTI indication, which looks good, and the BSI indication, which looks fraught.
The US FDA's the Antimicrobial Drugs Advisory Committee will convene May 2 to evaluate the safety and efficacy of Achaogen Inc.'s plazomicin sulfate injection in what appears to be the first drug being reviewed by the agency under the 21st Century Cures' limited population (LPAD) pathway.
But the aminoglycoside antibiotic is likely to face concerns from the committee over the Phase III trial evaluating the drug...
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.
