Pediatric studies of promising cancer drugs can begin before the ideal dose is identified for adults, although some dose optimization work in children may be better left to the postmarket setting, advisory committee members said.
Pediatric studies of promising cancer drugs can begin before an optimized dosage is identified for adults, but there should be a prospect for clinical benefit in pediatric patients and, ideally, an age-appropriate formulation, the US Food and Drug Administration and its external experts said at a recent advisory committee meeting.
While FDA officials said they recognize that premarketing randomized trials for dosage optimization may not always be possible, some panelists...
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.
