As the mosquito-borne chikungunya virus spreads into temperate regions worldwide, US FDA convenes advisory committee for an open discussion on development of vaccines.
Themis Bioscience GmbH will lay out plans for pre- and post-licensure studies to support approval MV-CHIK, one of the first chikungunya virus vaccines to approach pivotal clinical trials, as part of the US Food and Drug Administration's Vaccines and Related Biologic Products Advisory Committee topical meeting on 8 November.
Chikungunya virus (CHIKV), carried by Aedes aegypti mosquitos, largely had been confined to self-limiting outbreaks in Asia and Africa until...
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.
