Most advisory committee members supported approval of the breast cancer imaging product, but indicated labeling and advertising should be carefully crafted to avoid overhyping the likelihood patients experience a clinical benefit.
Lumicell Inc.’s breast cancer imaging drug provides an important, if incremental, benefit that outweighs the manageable risks of anaphylaxis, a US FDA advisory panel concluded on 5 March.
The Medical Imaging Drugs Advisory Committee voted 16-2 with one abstention in favor of Lumisight (pegulicianine) to be used in...
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.
