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

Advances in health-related software, such as smartphone or smartwatch patient-compliance software, or cellphone camera software used to monitor adverse events and cognitive performance, are getting a boost in the approval process by not being required to get separate approval by the Center for Devices and Radiological Health. In this article, FDA Commissioner Scott Gottlieb weighs in on these changes, and Pink Sheet looks at their possible implications for combination products and as a means of cutting development c.