Efficacy Supplement

Preferred Label : Efficacy Supplement;

Alternative definition : FDA: For NDAs, ANDAs, and BLAs, this represents an application to modify the current indications or claims for a use for which the application was previously approved/licensed. Efficacy supplements may only be submitted once the original-application has been approved/licensed.;

Details

Origin ID

C97103;

UMLS CUI

C3273234;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- FDA eCTD Terminology [NCIt concept]
- Regulated Product Submission Reporting Terminology [NCIt concept]
- eCTD Submission Type Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

You can consult :

All resources
or only the major
or use the search engine

recommendations
documents concerning education
documents for patients