The U.S. FDA has recently proposed a new draft framework that enables pharma manufacturers to add software to a drug label if they can demonstrate that the software adds clinical benefit to the drug. This prescription drug use-related software (PDURS) framework would allow for the pairing of a companion app to a drug without restrictions of anti-kickback laws and/or the rigor of drug-device combination approvals, while supporting greater clinical value, brand differentiation, and extended lifetime value.
In a first-of-its-kind fireside chat, pharmaphorum editor-in-chief Jonah Comstock sat down with Marty Culjat, SVP, global head of digital medicine and regulatory innovation at EVERSANA and Ed Cox, head and general manager of digital health and medicines (DHM) at Pfizer, to get the word out about this new regulatory paradigm and discuss its potential impact on the pharmaceutical industry
Author
Marty Culjat, PhD is the SVP, Global Head of Digital Medicine & Regulatory Innovation at EVERSANA. In this role, he leads a cross-functional team supporting the commercialization of digital medicine products within companies ranging…