FDA regulation of pharma apps: the story so far

Your weekend read. Bradley Merrill Thompson of Epstein, Becker writes at length (three pages!) over at Mobihealthnews on where FDA is going in regulating pharmaceutical apps. This is a proliferating area, with only 100 or so now available but many times that number in development. Surprisingly, many of these apps may act as decision support software that may enable certain drugs to move to over-the-counter. And FDA may actually deregulate select apps used for low-risk med management. The article reviews and discusses categories: regulatory (even if FDA doesn’t touch your app, the Federal Trade Commission will), professional apps (drug labeling, decision support), and patient apps–the most interesting being a ‘condition of drug sale’ or CDS. How the FDA regulates pharmaceutical apps