Regulating Medical Innovation in the Digital Age
Over the last decade, the Food and Drug Administration has worked hard to take a more nimble approach to regulation, increase the number of approvals, prioritize truly innovative products, and integrate patient perspective into its evaluations. Now the agency is facing challenges relating to regulating medical products in the digital age - digital health technologies, machine learning algorithms, integration of data and evidence from non-traditional sources, digiceuticals, and adaptive trials based on complex biostatistical methods, and more. Is the agency prepared to regulate this brave new world unfolding at warp speed? What are the promises and potential pitfalls of these new technologies for patients?