Concept information
Preferred term
new drug application
Definition
- 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]
Broader concept
Belongs to group
URI
http://data.loterre.fr/ark:/67375/N9J-B8JVSHTB-F
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