US advisory committee rejects Repros Therapeutics' proposal for an obesity-related hypogonadism study in which efficacy is based upon testosterone levels and sperm concentrations.
Clinical trials of drugs intended to treat secondary hypogonadism should be premised upon symptom-based endpoints and fertility measures, an FDA advisory committee said Dec. 6.
In a series of votes on different treatment scenarios and patient populations, members of the Bone, Reproductive and Urologic Drugs...
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.
