Presubmission Accelerated Non-Launch Material

Preferred Label : Presubmission Accelerated Non-Launch Material;

NCIt related terms : Presubmission Accelerated Non-launch;

Alternative definition : FDA: Promotional materials intended to be used after the 120 day post-approval period that are submitted to FDA prior to dissemination/publication as required by 21 CFR 314.550 and 601.45.;

Details

Origin ID

C97012;

UMLS CUI

C3273183;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- FDA eCTD Terminology [NCIt concept]
- eCTD Promotional Material Document Type Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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