Preferred Label : Biologics License Application;
NCIt related terms : Biologics licensing application (BLA); Biologic License Application (BLA); BLA;
NCIt definition : A formal submission to FDA from any legal person or entity to obtain permission for
manufacturing and marketing a biological product subject to licensure under section
351 of the Public Health Service Act. A biologics license application must contains
specific information on the manufacturing processes, chemistry, pharmacology, clinical
pharmacology and the medical affects of the biologic product, sufficient for the FDA
to determine that the establishment and the product meet applicable requirements to
ensure the continued safety, purity, and potency of the product, including but not
limited to GMPs.;
Alternative definition : CDISC-GLOSS: Biologics licensing application (BLA). an application to FDA for a license
to market a new biologic product in the United states.; FDA: A category specifying that a product is marketed under a Biologic License Application.; PQCMC: PQCMC data submitted to a biologics license application.;
Origin ID : C71778;
UMLS CUI : C2347025;
Semantic type(s)
- concept_is_in_subset
