A switch from Republican to Democratic control of the White House in 2008 could have tangible, near-term policy implications for FDA device and diagnostic oversight and postmarket study requirements, according to a former deputy commissioner with FDA
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A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.
Luna Health has raised $23.6m in Series A funding to support regulatory submissions, clinical studies and manufacturing for its insulin patch pump.
