At advisory committee meeting on Acrotech's two peripheral T-cell lymphoma drugs, FDA reviewers suggest they are more willing to seek product withdrawal for failure to conduct studies with due diligence when there are numerous available therapies.
The therapeutic landscape weighs heavily in the US Food and Drug Administration’s evaluation of the diligence with which accelerated approval sponsors conduct confirmatory trials and whether those drugs should be removed from the market.
The FDA’s focus on the therapeutic landscape repeatedly was emphasized during the 16 November Oncologic Drugs Advisory Committee meeting on...
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.
