A new molecular entity (NME) is a drug that contains no active moiety that has been approved by the US Food and Drug Administration (FDA). It has not yet been assigned a therapeutic equivalence rating. The official FDA definition states: "The term "new molecular entity" means an active ingredient with no active moiety that has been approved by the FDA in any other NDA (new drug application)".
A new molecular entity is biologically active and bears no relation to existing drugs. However, it may contain a common element or group of elements that are found together in various other known substances. The main feature of NMEs is that they show pharmacological properties under investigation, but have not yet been approved.
A drug can be defined as a product that is administered to humans and other animals for the treatment, prevention, and diagnosis of disease. The aim of producing such drugs is to improve their therapeutic value for patients. A new chemical entity (NCE) is a substance whose composition differs from those previously approved by the FDA in any way.
It may be a drug that contains no active moiety, but whose composition is different from those already approved. A new chemical entity must be biologically active and have pharmacological properties under investigation, but has not yet been approved. This category is further divided into two groups: Group I includes compounds found in the environment or derived from natural sources, while group II poisons and compounds produced by metabolism.
The cost of drug development varies depending on which phase the research is in, and whether it is a brand-new compound or an existing one that has been reformulated.
There are many cost drivers involved in the development of a new drug, some of which include:
NCE costs are likely influenced by the complexity of the drug. For instance, NCEs that are developed to target multiple receptors or enzymes can cost more than $1 billion; this is estimated by the Tufts Center for the Study of Drug Development (CSDD). In May 2019, gave an estimated cost of $2.6 billion. That study broke down the number to include approximate average out-of-pocket costs of $1.4 billion and time costs of $1.2 billion.
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