Advisory committee tells FDA that the agency, not vaccine manufacturers, should dictate the conversation around variants and reformulations; panelists also want better government research on immune correlates of protection ahead of any decision on a composition change.
The US Food and Drug Administration should take a more activist role in the development and evaluation of modified COVID-19 vaccine formulations targeted at new variants, the agency’s external experts said 6 April.
The agency should tell manufacturers which variants and formulation types they should focus their research efforts on, rather than 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.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
