Departing Commissioner says that special government employee procedure especially is in need of reform.
The US FDA could change its advisory committee process in an effort to ensure it can access the best experts. Former Commissioner Robert Califf, in one of his last acts as head of FDA, wrote in a Jan. 18 blog post that the agency was pondering modernizing and streamlining its advisory committee meeting planning as well as its member screening processes.
Califf said that FDA "must engage in wide-ranging discussions inside and outside FDA about the best ways for the agency...
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.
