FDA should consider allowing sponsors in challenging area of single species antibacterials more flexibility in study designs, advisory committee suggests, despite disagreement over approaches such as animal models and non-inferiority trials.
FDA should consider allowing sponsors of treatments targeting a single species of bacteria to select from, and possibly combine, studies from a menu of options to evaluate safety and effectiveness, FDA's Antimicrobial Drugs Advisory Committee suggested in a recent discussion.
The agency did not pose voting questions to the panel at its April 13 meeting. But the discussion indicated general...
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.
