FDA Seeks To Prevent Opioid Overdoses Through Its First-Ever Mobile App Challenge

FDA announced Monday (Sept. 19) its first-ever mobile app competition for development of an app to connect those suffering from an opioid overdose to those carrying the overdose antidote Naloxone. An FDA official declined to comment on whether the winning app would be subject to premarket review, despite the fact the agency announced less than two months ago that it does not intend to regulate low-risk general wellness apps. One industry source saw the announcement as evidence of the agency's...