Gottlieb Unveils Digital Health Tools For Drug Development, Pre-Cert Model

By David Roza / April 26, 2018 at 4:20 PM
In a speech at Datapalooza on Thursday (April 26), FDA commissioner Scott Gottlieb announced a slew of new agency initiatives aimed at spurring use of data analytics and digital health tools in regulatory decision making and drug development. The agency also unveiled a working model for its emerging digital health software precertification program, as well as a draft guidance clarifying FDA will take a hands-off regulatory approach toward certain functions of digital devices that don't directly affect the product's safety...

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