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The FDA moved its digital health efforts along via the release of one final and two draft guidances, including a final guidance for software as a medical device, but one longtime observer of the digital health scene characterized the draft guidance for clinical decision support systems as "extremely troublesome."

In a move that likely will increase the craving of some U.S. lawmakers for the importation of cheaper drugs from Canada, the Canadian government is proposing revisions to its Patented Medicines Regulations to make prescription drugs even more affordable in that country.

Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare & Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.

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