Annals of Clinical Trials and Vaccines Research

Open Access Articles For New Chemical Entities

 A new chemical entity (NCE) is, consistent with the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in the other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. A new molecular entity (NME) may be a drug that contains a lively moiety that has never been approved by the FDA or marketed within the US. An NCE may be a molecule developed by the innovator company within the early drug discovery stage, which after undergoing clinical trials could translate into a drug that would be a treatment for some disease. Synthesis of an NCE is that the initiative within the process of drug development. They can either choose clinical trials on their own or license the NCE to a different company. Companies adopting this model of business would be able to generate high margins as they get a huge one-time payment for the NCE as well as entering into a revenue sharing agreement with the licensee company. Under the Food and Drug Administration Amendments Act of 2007, all new chemical entities must first be reviewed by an advisory committee before the FDA can approve these products.   New chemical entity means a drug that contains no active moiety that has been approved by FDA in the other application. 

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