FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Drug Safety? There (Should Be) an App for That, FDA Says

Nov. 28, 2018
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The FDA is seeking public comment on how it should regulate prescription drug software apps and says some apps might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer.

“Our aim is to establish a bright line between those apps that are coupled to drugs in a way that require their review as part of the pre-market drug application and those apps that can be safely advanced to patients without pre-market review,” Commissioner Scott Gottlieb said in remarks to a Reagan-Udall Foundation meeting on real-world evidence at the agency’s campus in Silver Spring, Maryland. “[T]hese lower-risk apps can be subject to post-market surveillance and monitoring,” he added, inviting public comment on a proposed framework for regulating such apps.

The agency says it’s leaning toward a light-touch approach to digital drug apps but wants to hear from the public before making any decisions.

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