Preferred Label : Single-entity Product;
NCIt definition : A product composed of two or more regulated components (i.e., drug/device, biologic/device,
drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise
combined or mixed and produced as a single entity. (21 CFR 3.2 (e) FAQ);
Alternative definition : CDISC-GLOSS: A product composed of two or more regulated components (i.e., drug/device,
biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically,
or otherwise combined or mixed and produced as a single entity. [After 21 CFR 3.2
(e) FAQ] See also combination product, co-packaged product, cross-labeled product.;
NCI Metathesaurus CUI : CL979039;
Origin ID : C165836;
UMLS CUI : C5237477;
Semantic type(s)
- concept_is_in_subset
