New Drug Application

Preferred Label : New Drug Application;

NCIt related terms : New Drug Application (NDA); NDA;

NCIt definition : A regulatory document submitted to the FDA proposing the approval of a new drug to be marketed and sold in the U.S. It includes supporting data from both animal and human studies that was initially provided in the Investigational New Drug application (IND).;

Alternative definition : CDISC-GLOSS: An application to FDA for a license to market a new drug in the United States.; FDA: A type of application which a pharmaceutical manufacturer or its agent requests permission from the United States Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications; besides a chemical and pharmacologic description of the drug, the application must show the results of clinical trials conducted with respect to the indication for which a license is requested.; PQCMC: PQCMC data submitted to a new human drug application.;

Details

Origin ID

C72899;

UMLS CUI

C2347344;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
- FDA Application Type Terminology [NCIt concept]
- FDA CDRH GUDID Terminology [NCIt concept]
- FDA Pharmaceutical Quality/CMC Terminology [NCIt concept]
- FDA Quality Metrics Terminology [NCIt concept]
- FDA eCTD Terminology [NCIt concept]
- PQ/CMC Stability Study Reason Terminology [NCIt concept]
- eCTD Application Type Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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