Preferred Label : Resubmission;
NCIt definition : A submission that has been altered and resent.;
Alternative definition : FDA: A submission that contains additional information for the Agency to consider
following the issuance of an action communication to the applicant (e.g., complete
response or inactivation). For promotional labeling and advertising, the submission
of revised promotional materials that were previously submitted as an original submission
sub-type. Includes requests for advisory on launch materials, requests for advisory
on non-launch materials, pre-submission of promotional materials for accelerated approval
products, and materials submitted pursuant to 503B.;
Origin ID : C97106;
UMLS CUI : C3273237;
Semantic type(s)
- concept_is_in_subset
