Although US FDA wants sponsors to maintain blinded Phase III follow-up as long as possible after emergency use authorization or licensure, vaccine researcher Larry Corey says it will become ‘untenable’ to keep individuals in placebo arm once they qualify for vaccine access under the allocation framework.
The timing of when individual placebo patients in randomized Phase III trials of COVID-19 vaccines should be allowed access to those vaccines once authorized or licensed by the US Food and Drug Administration may depend upon the number of doses available and the populations prioritized for initial distribution.
Larry Corey, a virologist at Fred Hutchinson Cancer Research Center and co-leader of the COVID-19 Prevention Network’s vaccine testing program,...
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.
