The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June-an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market.
The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June-an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market.
The FDA issued new draft guidance that stated its intent to not actively regulate certain health IT devices. It also signaled that IT products that straddle the line between IT and devices would also be exempt. This is good news for mHealth solution developers and health sciences organizations engaged in clinical development, clearing the way for faster development and more confident adoption.
In this Applied Clinical Trials article, Oracle Health Science’s Mukhtar Ahmed outlines mHealth technologies’ potential to transform clinical development programs, including clinical trials.
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