US FDA Office of Antimicrobial Products Director Ed Cox explained to an advisory committee why a non-inferiority analysis could work in the context of an unmet need.
The 21st Century Cures Act equipped the US FDA with the flexibility to approve antimicrobial drugs based on a limited population if the drug treats a life-threatening infection in a limited population of patients with unmet needs, creating with is known as the "LPAD" pathway. But can a non-inferiority analysis be used for an LPAD indication in the context of unmet needs?
It is possible, FDA officials say, at least in the context of Achaogen Inc.'s plazomicin. (Also see "Plazomicin's...
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.
