Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith, Senior Editor Sue Sutter, Managing Editor Bridget Silverman and Executive Editor Nielsen Hobbs discuss the reasons the US Food and Drug Administration has scheduled only one drug-related advisory committee meeting in 2024 so far (:29), the role of the US Centers for Medicare and Medicaid Services in drug importation efforts (14:22), and the 2023 increase in missed FDA user fee goals (27:30).
Pink Sheet Podcast: US FDA Adcomm Schedule, CMS And Drug Importation, Missed User Fee Goals
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Pink Sheet reporters and editors discuss the nearly wide open 2024 FDA advisory committee calendar, CMS’s impact on Florida’s drug importation plan, and the FDA’s many missed user fee goals in 2023.
Learn what's happening at the US FDA. On the go.
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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.
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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.
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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.
