Back كيان كيميائي جديد Arabic Nueva entidad química Spanish 新規化学物質 Japanese New chemical entity NB Nevi hemijski entitet Serbo-Croatian Nevi hemijski entitet Serbian 新化学实体 Chinese
A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a novel, small, chemical molecule drug that is undergoing clinical trials or has received a first approval (not a new use) by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.[1]
A new molecular entity (NME) is a broader term that encompasses both an NCE or an NBE (New Biological Entity).
- ^ "Archived copy" (PDF). Food and Drug Administration. Archived from the original (PDF) on 2017-02-09. Retrieved 2019-12-16.
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