Preferred Label : Regulatory Assessment Code;
NCIt related terms : RegulatoryAssessment.assessmentCode;
NCIt definition : A coded value specifying the regulatory designation made by the regulatory authority.;
Alternative definition : BRIDG 3.0.3: 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. 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.;
Origin ID : C94050;
UMLS CUI : C2986248;
Semantic type(s)
- concept_is_in_subset
