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Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

 
• By Michael Cipriano

The agency explains that most drug-use-related apps will be considered promotional labeling, but sponsors should sometimes seek advisory comment. US FDA is seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-drug-focused software.

Touch the future,Interface technology, the future of user experience.

US FDA anticipates that sponsors will generally not need to obtain pre-market approval for the output of prescription drug-use-related software, although the agency is also encouraging companies use the voluntary advisory comment process in certain cases.

In officially announcing its discussion proposal in a Nov. 20 Federal Registernotice, FDA recommended drug-makers use the advisory process when "the use of the prescription drug-use-related software output may...

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