Innovation and FDA’s Regulatory Frameworks: Catalyst Co-Authors Explore How the Coming Data Shift Will Impact Medical Product Regulation in Therapeutic Innovation & Regulatory Science Article

Given rapid advances in technology and our understanding of disease, the future will bring a shift in how the health care system thinks about and uses data, Michael Doherty, Foundation Medicine/former Roche Head of Strategic Innovation and Catalyst co-authors Nancy Bradish Myers and Anne Petruska McNickle say in an article in Therapeutic Innovation & Regulatory Science.

The article, “The Impact of Innovation: How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework,” anticipates a shift away from the milestone-based approach to data to a continuous, contextual approach; this data shift will mean the way in which medical products are regulated will have to evolve, with potential implications across the regulatory landscape, from drug development and review to labeling and the postmarket setting.