Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.
The official 351(k) pathway for biosimilar products was created in the Biologics Price Competition and Innovation Act, a component of the health care reform law. Listed below are biologics license applications (BLAs) submitted under that pathway.
Biosimilar sponsors also can submit their products using the 505(b)2 NDA or conventional BLA pathways; those applications are only listed...
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.
