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Policy Category: Regulation

PMC advises regulators on public policies that can help facilitate the efficient review of personalized medicine products. For example, PMC explained how certain enhancements to the U.S. Food and Drug Administration (FDA)’s drug and medical device user fee programs could help advance personalized medicine while participating in a series of public workshops FDA convened to discuss the user fee programs in 2020, 2021, and 2022. Many of PMC’s recommended changes went into effect with the passage of new user fee reauthorization laws in 2022.

FDA’s Oversight of Development and Labeling for In Vitro Companion Diagnostic Devices in Oncology

FDA’s Oversight of Gene Therapies

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

FDA’s Oversight of Diagnostic-Drug Co-Development

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

FDA’s Oversight of In Vitro Diagnostic Multivariate Index Assays

FDA’s Policies in Pharmacogenomics

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