Pink Sheet infographic tracks US regulatory forecast for the many new vaccines facing the twin tests of FDA approval and CDC recommendation, which are both needed to effectively access the US commercial marketplace.
The height of the COVID-19 pandemic is in the rear view, but the vaccine pipeline promises plenty of other activity in the coming year in established markets like respiratory syncytial virus as well as emerging diseases like dengue, mpox and chikungunya, a Pink Sheet infographic analysis shows.
A battle royale is brewing in RSV, where GSK plc and Pfizer Inc. are vying to launch the...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
