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 (...
Japanese digital health company Welby has collaborated with Janssen, a pharmaceutical division of Johnson & Johnson, to develop a mobile app for people with attention deficit hyperactivity disorder, or ADHD. The app will be available on iOS and Android throughout Japan.
Aozora, the task management app, was created by Welby and will be distributed by Janssen to people with ADHD who are...
Sixty-six percent of all pharma app downloads in the United States, the United Kingdom, and Germany, were downloads of the top 10 apps according to an infographic recently released by German app company SmartPatient (not to be confused with Roni Zeiger-founded online patient community SmartPatients). SmartPatient's iOS and Android app is called MyTherapy.
The Munich-based company analyzed 359...
Indianapolis-based pharma giant Eli Lilly is opening a new drug delivery and innovation center in Kendall Square in Cambridge, Massachusetts. Construction will begin immediately, with the center opening by the end of the year for a planned staff of 30 scientists and engineers.
Eli Lilly Senior Director of Global Corporate Communications Edward Sagebiel said one Eli Lilly executive will move to...
By Bradley Merrill Thompson
Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps. Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well...
Pharmaceutical companies have a lot of apps in the market, and have been making apps for a long time, but their apps aren't seeing downloads and usage on par with the apps from other industries. That's the conclusion of a new report from Research2Guidance (R2G), which analyzed more than 725 apps from 11 pharma companies.
According to R2G, the top pharma companies have 65 apps in the Apple and...
TapTrak's forthcoming clinical trials app.
Medical micro-journaling startup tapTrak has formally hired pharma veteran Efren Olivares, a hire that signals the company's upcoming expansion into the pharma space.
New York City-based tapTrak, which raised $390,000 in seed funding last July, began its life in 2011 as a consumer-focused quantified self app, to make it easy for people to track and...
