Advisory committee offers strong support for approval of Pfizer’s RSV vaccine to protect infants while simultaneously offering the agency a handful of suggestions that were directed towards the review and post-market surveillance of all vaccinations.
Pfizer Inc.’s maternal respiratory syncytial virus vaccine program got positive efficacy and safety votes from the US Food and Drug Administration’s vaccine advisors 18 May with the strong caveat from many members that rigorous post-marketing surveillance be required as part of an expected approval.
The Vaccines and Related Biological Products Advisory committee voted unanimously that Pfizer’s data package for Abrysvo (RSVpreF) is adequate to...
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.
