The CDC’s Melinda Wharton discusses how the ACIP handled COVID-19 and how the pandemic will shape the committee’s work in the future.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is coming up for air after years of an extra-heavy workload due to the COVID-19 public health emergency and evaluating how to structure its work moving forward.
The bolus generated by the pandemic revealed that basic committee processes are sound, said CDC’s Associate Director for Vaccine Policy...
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.
