What does NME mean in FDA
A New Molecular Entity (NME) is a term used to describe a brand-new active pharmaceutical ingredient or drug that has been approved by the U.S. Food & Drug Administration (FDA). An NME is created when a company develops and manufactures a drug substance, or active pharmaceutical ingredient, which has never before been approved in any form. This can be done through the discovery of novel chemical compounds, modifications of existing drugs, or biotechnological methods.
NME meaning in FDA in Governmental
NME mostly used in an acronym FDA in Category Governmental that means New Molecular Entity
Shorthand: NME,
Full Form: New Molecular Entity
For more information of "New Molecular Entity", see the section below.
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Essential Questions and Answers on New Molecular Entity in "GOVERNMENTAL»FDA"
What is an NME?
An NME stands for New Molecular Entity and refers to an active pharmaceutical ingredient or drug that has been approved by the U.S. Food & Drug Administration (FDA).
How do companies create new molecular entities?
Companies create NMEs through the discovery of novel chemical compounds, modifications of existing drugs, or biotechnological methods.
Is an NME only approved by the FDA?
Yes, in order for a drug to be considered an NME it must be approved by the FDA before it can enter into circulation in the United States.
Are all new drugs automatically considered an NME?
Not necessarily; a drug may be considered new but not meet all criteria for being classified as an NME. The criteria set forth by the FDA are sometimes quite specific and must be met in order for a drug to be considered an NME.
Does approval of an NME mean it is safe for use?
No, just because a drug has been granted approval status as an NME does not guarantee its safety or efficacy; rigorous clinical trials are still necessary to test these properties before introducing them into public use as medications or treatments.
Final Words:
A New Molecular Entity (NME) represents something truly unique — a brand-new active pharmaceutical ingredient or drug that has never before been approved in any form and which is created through innovative research efforts and technologies such as novel chemical compounds, modifications of existing drugs, or biotechnological methods. Such innovations are monitored closely by the FDA prior to their release on the market for public use.
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