The Importance of Correct New Drug Designations: New “Novel Drug Entity” Designations
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.
Authors
- Israel Agranat (ORCID: https://orcid.org/0000-0001-5247-1523)
- Sarah K. Branch (ORCID: https://orcid.org/0000-0002-6329-5761)
Institutions
- Hebrew University of Jerusalem (IL)
Publication Details
- Journal
- ACS Medicinal Chemistry Letters
- Published
- 2025-06-30
- DOI
- https://doi.org/10.1021/acsmedchemlett.5c00320
- Citations
- 1
- Primary Topic
- Computational Drug Discovery Methods
- Type
- article
- Field-Weighted Citation Impact
- 1.50