Policy Category: Science Policy

FDA’s Oversight of Gene Therapies

Personalized Medicine and Value Assessment Frameworks: Context, Considerations, and Next Steps

European Medicines Agency’s 2017 Concept Paper on Predictive Biomarker-Based Assay Development

FDA’s Oversight of Next-Generation Sequencing-Based In Vitro Diagnostics

The Patient-Centered Outcomes Research Institute’s Priorities and Methodologies

Legislation Designed to Promote Comparative Effectiveness Research

A Report on Comparative Effectiveness Research and Personalized Medicine: From Contradiction to Synergy

Scientific Validity of Personal Genetic Health Testing: 2008

FDA’s Oversight of In Vitro Diagnostic Multivariate Index Assays