Five novel agents have user fee goal dates in the coming month, the Pink Sheet’s US FDA Performance Tracker shows.
The user fee goal dates for Junshi Biosciences/Immorna Joint Venture/Coherus BioSciences, Inc.’s PD-1 inhibitor toripalimab and HUTCHMED (China) Limited’s angio-immuno kinase inhibitor surufatinib bookend the month of April, providing the US FDA more chances to define its stance on the recent wave of oncology applications based on Chinese trial data.
In between toripalimab’s 1 April and surufatinib’s 30 April 2022 user fee dates are the FDA decision goal dates for...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
