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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| 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
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| Series: | INNOVATIONS in Pharmacy |
| Subjects: | |
| Online Access: | https://pubs.lib.umn.edu/index.php/innovations/article/view/6461 |
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