Senate Adopts Cures Bill By Big Margin; FDA Could Tap $20m More In 2017
The Senate approved the same 21st Century Cures bill passed by the House last week on a 94-5 tally; the bill is expected to be quickly signed by President Obama. Provisions for extra dollars for FDA in the bill means that even with a plan by Congress to adopt a continuing resolution this week freezing FDA funding until April 28, the agency can rely on an additional $20 million set aside for it in Cures in the new year.
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The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
In his Jan. 30 State of the Union address, President Trump praised US FDA for its high approval rate of devices and drugs in 2017, and urged Congress to do more by approving 'right-to-try' legislation that he says would allow terminally ill patients to gain access to experimental devices and drugs.
The deadline has been bumped back to mid-March following a request from industry trade group AdvaMed.