After split verdicts on efficacy and safety for Sanofi’s proposed population for the dengue vaccine, FDA added two new questions limited to pediatric use, which drew strong advisory committee support.
Sanofi emerged from a challenging US FDA advisory committee review of Dengvaxia with strongly positive votes on two of four questions posed to the panel, thanks in large part to the agency’s own apparent enthusiasm for the controversial dengue vaccine.
Throughout the March 7 meeting of the Vaccines and Related Biological Products Advisory Committee, staff in the Center for Biologics...
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.
