GSK’s measles, mumps and rubella vaccine is on track for June decisions by both US FDA and CDC Advisory Committee on Immunization Practices.
GlaxoSmithKline plc’s measles, mumps and rubella vaccine Priorix is teed up for a recommendation from the US Centers for Disease Control and Prevention shortly after what the company hopes will be a US FDA approval by the product’s June 2022 goal date.
The CDC may not approve products, but the recommendations of its Advisory Committee on Immunization Practices make the market for...
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.
