Drug/Software Combo Pathway Coming Soon To US FDA, Gottlieb Says

Under a new regulatory platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate pre-market device review.

Data synchronization of health book between smartwatch and smartphone in male hands

US FDA expects to soon release its "digital health tools" platform that will allow software applications to be approved in conjunction with new drugs and included in labeling.

Under the plan, the software applications may not require separate approval by the Center for Devices and Radiological Health. Commissioner...