Preferred Label : Post Marketing Requirement;
NCIt related terms : postmarketing requirement (PMR); Post-marketing Requirements or Post-marketing Commitments;
Alternative definition : FDA: Post-marketing Requirements (PMR)/Post-marketing Commitments (PMC) related submissions
not covered under annual report and supplements. These generally would be administrative
type PMR/PMC related submissions, for example, non-supplement final study reports
and status update reports for BLS non-reportable (non 601.70) PMCs, etc. or Non-supplemental
final study reports to an IND or NDA, if labeling is not changing. Non-annual report
IND amendments.; CDISC-GLOSS: FDA-required postmarketing studies or clinical trials. [FDAAA; 21 CFR
Part 314, subpart h; 21 CFR Part 601, subpart e] Compare to postmarketing commitment
(PMC).;
Origin ID : C97025;
UMLS CUI : C3273195;
Semantic type(s)
- concept_is_in_subset
