Regulation, by its nature, hinders some activity, says Napoleon Monroe, managing director, New Directions.
“But regulation is also necessary to ensure product safety and efficacy, and an efficient, functional capital market,” he says. “In the longer term, effective, efficient technology applied ethically in the patient’s interest will overcome regulatory barriers.”
In September 2013, the FDA issued a final guidance for mobile medical apps. This final guidance was long-awaited by developers of mobile medical apps and will provide clarity regarding which mobile apps are the focus of FDA oversight…