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

 
• By Michael Cipriano

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

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

The 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 they use the voluntary advisory comment process in certain cases.

In officially announcing its discussion proposal in a Federal Registernotice scheduled to be published Nov. 20, FDA recommended drugmakers...

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What India’s Digital Personal Data Protection Norms May Mean For Clinical Trials, Big Pharma GCCs

 
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More from Advanced Technologies

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

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• By Eliza Slawther

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