With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.
With Janssen Biotech Inc.’s one-shot COVID vaccine set for review by the US FDA’s Vaccines and Related Biologics Products Advisory Committee on 26 February, the sponsor and agency have a chance to learn from some of the shortcomings of the panel’s meetings last year.
FDA had a lot of practice conducting virtual meetings in the run up to the two historic and likely most...
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.
