As sponsors complain about difficult-to-implement ACIP recommendations hampering uptake, the government says developers share some of the blame, but adds that it is working to ensure recommendations can be operationalized.
If vaccine manufacturers want smoother uptake of their vaccines in the US, they may want to consider how they study and price them.
Vaccine manufacturers may need more comprehensive clinical trial data and better price points to get the preferred universal age-based recommendations from the CDC.
Complaints about difficult-to-implement Centers for Disease Control and Prevention vaccine recommendations hindering uptake took center stage at a World Vaccines...
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.
