Abstract
The Viewpoint addresses designations of novel drugs. The regulatory designation of new drugs is significant as it may confer exclusivity. The terminology for nonbiological drugs in the US is described. The Viewpoint recommends for approved novel drug compilations: novel molecular entity (nonbiological drug), novel biological entity, novel therapeutic entity for both designations.
| Original language | English |
|---|---|
| Pages (from-to) | 1217-1220 |
| Number of pages | 4 |
| Journal | ACS Medicinal Chemistry Letters |
| Volume | 16 |
| Issue number | 7 |
| DOIs | |
| State | Published - 10 Jul 2025 |
Bibliographical note
Publisher Copyright:© 2025 American Chemical Society.
Keywords
- New Chemical Entity (NCE)
- New Molecular Entity (NME)
- Novel Biological Entity (NBE)
- Novel Drug
- Novel Molecular Entity (NME)
- Novel Therapeutic Entity (NTE)
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