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the drug is subject to an open drug efficacy study, health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condition, and there is insufficient supply of an FDA-approved drug

Advances in predictive, preventive, personalized, and participatory (P4) medicine, supported by genomics, multi-omics, imaging, and real-world data, are presented as accelerating biomarker discovery and enabling earlier and more precise stage-specific interventions