CPC Comments on FDA’s Proposed Framework for Regulating Software Intended for Use with Prescription Drugs

On January 22, 2019, CPC provided input on the Federal Register Notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” While the CPC applauds the Agency’s efforts to develop a proposed framework to address the ever-increasing array of digital innovations associated with pharmaceuticals, the CPC has certain concerns regarding the proposed framework, as discussed within the comment letter.