Oncology Center of Excellence Director Richard Pazdur says he would like to see more diverse views during the OPH session, not just individuals curated by the sponsor to present ‘a very positive picture’ of the drug. An upcoming ODAC meeting will have everyone in-person except the OPH speakers, public and press.
The US Food and Drug Administration's Richard Pazdur would like to see the open public hearing portion of advisory committee meetings revert to a more neutral forum not dominated by sponsor-driven support.
“We really would like to have a more constructive public hearing” at Oncologic Drugs Advisory Committee meetings, Pazdur, director of...
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.
