Advisory committee agrees that a proposed study protocol could enroll patients but notes the outcome is foreseeable. Industry representative questions whether this postmarketing requirement is necessary.
A US Food and Drug Administration advisory panel had a lukewarm response to a proposed clinical trial design to assess the long-term efficacy of extended-release and long-acting opioids. Members said the design is feasible but the results are predictable.
The Anesthetic and Analgesic Drug Products Advisory Committee discussed the study protocol at its 19 April meeting. The agency requested...
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.
