FDA consulting on software for drugs

Today the FDA announced they will invite submission on the treatment of digital supports to patients such as APP's, dose calculators and dose reminders associated with Pharmaceutical introduction. The intent apparently is to decide if such drug supports from Pharma can be examined and dealt with under "approved labelling". This would mean a more streamlined approach to approval and is something sensible and overdue.

The stance of FDA signals the move to empower patients further by providing them with tools and information aids to better manage their medication and their health. We applaud efforts to support patients become more knowledgeable and confident in dealing with their conditions, especially in chronic conditions. After all, the one with most skin in the game is the patient - the more they can be supported and motivated to contribute to their improvement, the better.