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    Generic Drug-Device Combinations: A Framework for Understanding FDA Approval Requirements

    As innovations in drug delivery systems continue to emerge, so do the number of drugs with a device component. These so-called drug-device combinations include many types of products regulated by the US Food and Drug Administration (FDA), such as drugs prepackaged in inhalers and auto-injectors, transdermal patch delivery systems and various types of kits. This new breed of technologies raises several approval issues for would-be generic competitors, particularly when th...