Issue 6: Hybrid Medicines And 505(b)(2) NDA Approval Pathways
Source: Altasciences
Hybrid medicines are drugs based on a generic molecule and have a different route of administration, format, strength, or indication from the original reference product. They require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.
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Altasciences
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