The Impact of Innovation: How the Changing Nature of Data Will Challenge FDA's Regulatory Framework.

Rapid advances in technology and our understanding of disease will lead to a shift in how the health care system thinks about data, which will in turn challenge current regulatory constructs. In the future, there will be a shift away from milestone-based data to continuous, contextual data; we believe this data shift will impact the current model of medical product regulation, with potential implications across the regulatory landscape, reflecting the convergence of clinical development and clinical practice.