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Regulatory Briefs: FDA Meetings On Cancer Tests, Glaucoma Devices; DeLauro Questions Device Reclassifications

An FDA advisory panel will discuss PMAs for two molecular diagnostics for colorectal cancer screening in March. A February workshop will address clinical trial design for minimally invasive glaucoma devices. Rep. DeLauro speaks out about FDA device reclassifications. More regulatory briefs.

FDA’s Molecular and Clinical Genetics advisory panel will meet March 26-27 to discuss and vote on pre-market approval applications for two colorectal cancer screening technologies, the agency announced in a Feb. 5 Federal Register notice.

The first day of the public meeting will address Epigenomics Inc.’s Epi proColon in vitro diagnostic test to screen for colorectal cancer in patients at average risk of the...

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