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  • Regulatory NewsRegulatory News

    Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways

    The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products. Specifically, DRDs are medical devices that reference an already-marketed drug when the drugmaker does not want to work with the device sponsor to pursue the new use. FDA says it sees three situations where DRDs could be proposed: ...