In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.
Some sponsor meetings with US Food and Drug Administration staff will return to partially face-to-face later this month and if the process moves smoothly, any meeting could be made in-person by the end of the year.
Sponsors had been complaining that their requests for in-person sessions with agency staff, as well as advisory committee meetings, had...
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.
