pharma companion apps

Proposed framework lessens FDA's regulatory requirements for prescription drug companion apps

By Dave Muoio 11:19 am November 19, 2018

The FDA is seeking public comments for a proposed framework that would allow the majority of apps and software released by pharmas that accompany a drug treatment to avoid lengthy premarket review submissions. According to a notice released last week, such software would be viewed as “promotional labeling,” and therefore only require submission to the FDA’s Office of Prescription Drug Promotion (...

AstraZeneca taps Voluntis for ovarian cancer treatment companion app

By Jonah Comstock 11:36 am December 7, 2015

French companion app company Voluntis has partnered with AstraZeneca to develop an app for women undergoing treatment for ovarian cancer. Specifically, the app will help patients and clinicians manage the side effects of a combination therapy of the drugs cediranib and olaparib, which can cause hypertension and diarrhea. "AstraZeneca has a strong focus on the use of companion devices in drug...