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NDA

Bible DictionaryAids Glossary
an application made by a drug manufacturer to FDA requesting marketing approval of a new drug.
Bible DictionaryGlossary of HIV(AIDS)-Related Terms
An application submitted by the manufacturer of a drug to the FDA -- after clinical trials have been completed -- for a license to market the drug for a specified indication.
Bible DictionaryDrugs@FDA Glossary
 
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: U.S. Food and Drug Administration, Center for Drug Evaluation and Research. (About)
See also: UAA , VACCINATION , R C , WA , G(-)

 

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