After a high-profile FDA advisory committee rejection of potentially the first "Made In China" cancer drug in the US, from Innovent Bio and partner Lilly, many Chinese oncology companies are now quietly looking for the next step forward.
While some front-runners say the result was not surprising, many companies have already started quietly preparing for the next steps and one thing seems to be crystal clear: the US regulator certainly looks to be different this time around.
The Oncology Drug Advisory Committee (ODAC), serving as the outside expert council to the US Food and Drug Administration, voted...
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.
