Post-guidance Opportunities and Challenges with Prescription Drug Use-Related Software

FDA issued the much-anticipated guidance on PDURS in 2023. Issuance of the guidance satisfied a commitment under PDUFA VII. It follows on the 2018 announced framework for PDURS that outlined regulatory considerations for software used in conjunction with a drug, typically to support medication adherence. The guidance touches on a range of fascinating topics including insights on medical , advertising and promotion oversight and complex issues surrounding the definition of labeling. This should promise a robust discussion of how participants can maximize the value of software and can explore the data needed to satisfy FDA’s expectations. It will also facilitate an exploration of emerging areas for PDURS that extend beyond adherence, potentially improving patient experience and clinical outcomes. To facilitate a lively debate, I propose to recruit FDA participation in such a presentation as well as potential representation from colleagues in the legal and regulatory and/or digital product development arena.