# new chemical entity

> according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act

**Wikidata**: [Q13653001](https://www.wikidata.org/wiki/Q13653001)  
**Wikipedia**: [English](https://en.wikipedia.org/wiki/New_chemical_entity)  
**Source**: https://4ort.xyz/entity/new-chemical-entity