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]
Concepto genérico
Pertenece al grupo
URI
http://data.loterre.fr/ark:/67375/N9J-B8JVSHTB-F
{{label}}
{{#each values }} {{! loop through ConceptPropertyValue objects }}
{{#if prefLabel }}
{{/if}}
{{/each}}
{{#if notation }}{{ notation }} {{/if}}{{ prefLabel }}
{{#ifDifferentLabelLang lang }} ({{ lang }}){{/ifDifferentLabelLang}}
{{#if vocabName }}
{{ vocabName }}
{{/if}}