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Robert M. Kaplan

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Review Open access Aug 2026

Changes in evidence used for FDA Novel Drug Approvals: 2016-2024

Background The 21st Century Cures Act (2017) was enacted during a period of evolving FDA flexibility in evidentiary standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024. Methods We constructed a database of all novel FDA...

Aditya Narayan, Veronica L. Irvin, Amanda J. Koong et al. · 0 citations
Review Open access Aug 2026

Solutions to reduce healthcare costs and improve outcomes in diagnostics: safety nets, optimized navigation, and decision support

This framework introduces three diagnostic improvement archetypes that health systems can use to select and sequence interventions based on local failure points, operational feasibility, and reimbursement context, and offers a pragmatic approach for advancing diagnostic excellence across diverse care delivery settings.

Sierra Stingl Sauter, R. Jarral, Yan Wang et al. · 1 citation

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