ODAC's 17-18 June discussion of pediatric development plans for four investigational oncology agents will serve as a trial run of the technology platform and logistics for any future application-specific virtual advisory committee meeting, but without the stress associated with a pending application and a user fee deadline.
The COVID-19 outbreak has led the US FDA’s Center for Drug Evaluation and Research to dip its toes into the virtual advisory committee waters with a two-day panel review of pediatric development plans for four oncologic agents.
On 17-18 June, the Oncologic Drugs Advisory Committee’s pediatric oncology subcommittee will convene online to discuss issues related to the...
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.
