Preferred Label : New Molecular Entity;
NCIt related terms : new molecular entity (NME);
NCIt definition : A drug or biologic whose active ingredient contains no active moiety that has been
previously approved by the US FDA.;
Alternative definition : CDISC-GLOSS: A drug or biologic whose active ingredient contains no active moiety
that has been previously approved by the US FDA. NOTE: Certain drugs are classified
as new molecular entities (NMEs) for FDA review administrative purposes. [After US
FDA. (04/08/2024). Novel Drug Approvals at FDA. Retrieved from URL https://www.fda.gov/drugs/development-approval-process-drugs/novel-drug-approvals-fda#:
:text Certain%20drugs%20are%20classified%20as%20new%20molecular%20entities,products%20frequently%20provide%20important%20new%20therapies%20for%20patients.%20Webpage%20access%202024/04/18]
See also new chemical entity (NCE), moiety.;
Origin ID : C209467;
concept_is_in_subset
