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FDA regulations codified at 21 CFR 314.53 indicate that NDA holders must submit information on any patented active ingredients, formulations and compositions, or methods of use that could conceivably include devices for drug delivery

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Correlates of missed or late versus timely diagnosis of dementia in healthcare settings

doi: 10.1007/s00404-016-4136-4 67 SanchezAMPapaleoECortiLSantambrogioPLeviSViganPet al