The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. Recognizing the opportunities for increased use of digital technology with prescription drugs, the Agency is proposing a framework that would provide prescription drug sponsors the flexibility to develop and disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors’ communications about their products. The framework proposed in this notice focuses not on prescription drug-use-related software itself, but rather on the output of such software that is presented to the end user.
Download the notice here: Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments
