Pfizer intends to notify placebo patients that an EUA has been issued and offer the vaccine to keep them in the study, but FDA appears to want to maintain placebo control for as long as possible.
Pfizer Inc. and BioNTech SE intend to follow US Food and Drug Administration guidelines for coronavirus vaccine postmarket placebo controls, but will notify participants when an emergency use authorization is granted and unblind them should they choose to leave the study.
Pfizer’s plans to offer those study participants the vaccine in order to keep them in the study, but that may...
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.
