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Concept information

Término preferido

new drug application  

Definición

  • A New Drug Application (NDA) tendered to the federal Food and Drug Administration is the method in which drug sponsors summarize all the preclinical, clinical, and manufacturing information in order to gain U.S. commercialization of the drug product. [Source: Encyclopedia of Health Care Management; New Drug Application]

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URI

http://data.loterre.fr/ark:/67375/N9J-B8JVSHTB-F

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