FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with one or more of their prescription drugs.

FDA Commissioner Scott Gottlieb, M.D. touted the proposed framework in his remarks at the Reagan-Udall Foundation on 19 November: "We believe the flexible concepts we've put forward will encourage more drug sponsors to advance beneficial and innovative software apps with FDA-approved drugs and biologics."

In issuing this request for comment, the FDA signaled its intention to develop guidance on this topic, but clarified that this notice is not a guidance document itself, but rather is intended to generate discussion. Accordingly, the agency posed a series of questions (noted below) for stakeholders' input. We encourage interested parties to submit comments to this docket to help inform and shape the FDA's views in this developing area.

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