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This is Part 1 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act...
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of...
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical...
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT…
In the context of the Framework, DHTs are "systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses."