FDA chief scientist encourages Intarcia to request advisory committee review of CDER’s proposal to refuse approval of its drug-device diabetes treatment. CDER again denies Lexicon request for hearing on proposal to deny approval of its SGLT2 inhibitor.
Intarcia Therapeutics, Inc. has the chance to make its case before a US Food and Drug Administration advisory committee as to why the agency should not refuse to approve its new drug application for ITCA 650 (exenatide implant) for treatment of type 2 diabetes.
The company has been in a lengthy dispute with the Center for Drug Evaluation and Research over the risk of...
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.
