Advisory committee to vote on whether patients with interstitial cystitis, marked by Hunner's lesions, should be studied separately from the broader, more heterogeneous category of patients with bladder pain syndrome; recommendations could impact Aquinox and Urigen, which have drugs for IC/BPS in clinical development.
Seeking to move the field forward in the treatment of interstitial cystitis and bladder pain syndrome, the US FDA is asking its external advisors whether patients with these conditions should be studied together or separated into distinct groups for drug development purposes.
FDA is convening the Bone, Reproductive and Urologic Drugs Advisory Committee Dec. 7 to discuss whether bladder pain syndrome (BPS)...
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.
