Development of Drug-Device Combination Products and Generic Substitution in the United States

Development of Drug-Device Combination Products and Generic Substitution in the United States

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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Bibliographic Details
Main Authors: YoonJung Lee, Ila Srivastava, Katharine B. Feibus, Elizabeth R. Bielski, Lolita Sterrett, Danielle Harris, Markham C. Luke
Format: Article
Language:English
Published: University of Minnesota Libraries Publishing 2025-07-01
Series:INNOVATIONS in Pharmacy
Subjects:
drug-device combination product
therapeutic equivalence
generic substitution
regulatory
generic
complex product
Online Access:https://pubs.lib.umn.edu/index.php/innovations/article/view/6461
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https://pubs.lib.umn.edu/index.php/innovations/article/view/6461

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