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US FDA Hoping To Solve Drug-Software Issues With Digital Health Working Group

 
• By Derrick Gingery

As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.

Medical app
The working group on digital wants to apply best practices from CDRH to CDER oversight of drugs with software components. • Source: Shutterstock

With software and drugs becoming increasingly intertwined, the US Food and Drug Administration is marshaling its expertise to make policy decisions and help application assessors.

The agency has established a working group on digital health that will address policy issues related to software that is...

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