Bob Temple and Ellis Unger discuss feasibility of studies for postpartum depression drug as advisory committee members wait to discuss the dosing questions they had been convened to consider.
The US FDA's internal conundrum with determining the dosing recommendation for SAGE Therapeutics Inc.'s proposed postpartum depression treatment brexanolone came into full view during the review by external advisors.
In a debate largely amongst themselves, agency officials illustrated that demanding answers to lingering questions about novel therapies is not...
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.
