On November 20, 2018, the Food and Drug Administration (“FDA” or “Agency”) published a Request for Comments about a proposed framework for regulating software applications (“apps”) disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. The proposed framework is a positive step, demonstrating that FDA recognizes the potential for improved health via access to software applications, and is committed to paving the way for further innovation.
This POV sets forth the scope of the proposed framework – what is and is not included, provides an overview of the proposed framework itself, and delivers recommendations for pharmaceutical companies involved in developing health-related apps.
Download the POV.