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New Drug Application (NDA)

Similar or Alternative Terms Meaning the Same Thing n/a
Related Term(s) New Molecular Entity (NME): A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form.

Definitions

When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number. Source: Food and Drug Administration


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