Prior Approval Supplement

Preferred Label : Prior Approval Supplement;

NCIt related terms : Prior Approval Supplement (PAS);

Alternative definition : FDA: Prior Approval (PA) Prior Approval Supplements supplement submission for a major change for which distribution of the product made using the change cannot occur prior to FDA approval as provided in 21 CFR 314.70 and 21 CFR 601.12.;

Details

Origin ID

C97027;

UMLS CUI

C3273197;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- FDA eCTD Terminology [NCIt concept]
- eCTD Supplement Effective Date Type Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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