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 (...
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...