With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.
Only half of the novel agents with user fee goal dates in the first half of 2022 received approval letters from the US FDA, reflecting a steep acceleration in a multi-year trend toward greater use of complete response letters.
The US FDA approved 19 novel agents during the first half of 2022 while issuing at least 14 complete response...
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.
