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    Development of Drug-Device Combination Products and Generic Substitution in the United States Tekijä YoonJung Lee, Ila Srivastava, Katharine B. Feibus, Elizabeth R. Bielski, Lolita Sterrett, Danielle Harris, Markham C. Luke

    Julkaistu 2025-07-01

    Generic drug products approved and marketed in the United States include a variety of drug classes and dosage forms along with drug-device combination products (DDCPs). Development of DDCPs can pose scientific, regulatory, and legal challenges, and the Food and Drug Administration (FDA) has priorit...

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