Preferred Label : Regulatory Assessment Result Code;
NCIt related terms : RegulatoryAssessment.resultCode;
Alternative definition : BRIDG 5.3: A coded value specifying the regulatory designation made by the regulatory
authority. EXAMPLE(S): For regular submissions the code can be: approved, not approvable,
approvable, complete response or cleared. For expanded access submissions the code
can be: Available, No longer available, Temporarily not available, or Approved for
marketing. OTHER NAME(S): NOTE(S): For some submissions, there are business processes
that will make default action based on timelines --i.e., if no action is taken, then
the submission is approved. For a submission, there may be multiple regulatory assessments
that correspond to the state transitions for a submission, but only one regulatory
assessment is true at a given time. A submission can first be approvable and then
when the data is complete, a new regulatory assessment can be made that is approved.;
NCI Metathesaurus CUI : CL978158;
Origin ID : C165067;
UMLS CUI : C5236858;
Semantic type(s)
- concept_is_in_subset
