US FDA's Peripheral and Central Nervous System Drugs Advisory Committee to consider application, which PTC Therapeutics filed over protest.
PTC Therapeutics Inc.'s controversial application in Duchenne muscular dystrophy is set for advisory committee consideration, potentially reigniting the sometimes passionate disagreements between FDA review staff and disease advocates.
The US FDA has scheduled a Sept. 28 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to...
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.
