Bradley Merrill Thompson, Member of the Firm, will present “Use of Mobile Medical Applications as Companions” at the DIA Meeting on Combination Products.
This session will explore the FDA’s final guidance, teasing apart exactly what types of apps in the pharmaceutical space will be regulated and which ones will not. To make the session more dynamic, attendees will explore several pre-prepared case studies that focus squarely on the difficult issues associated with applying that guidance to the pharmaceutical use cases. Three commentators will provocatively discuss the different possible interpretations of the guidance as applied to the case studies, and then the audience, using an electronic polling system, will vote to put the technology at issue into one of the following four categories: a.) Unregulated mobile app; b.) FDA regulated drug labeling; c.) FDA regulated medical device; or d.) FDA regulated medical device constituent part of a combination product. After seeing the audience poll, the panel will discuss whether they agree with the audience’s assessment.
For more information, visit DIAHome.org.