Assertion: trial | /r/HasProperty | submitted to the fda
Facets:
value: as part of an nda
type: CAUSE
Source sentences:
text: A 'covered clinical study' refers to a trial submitted to the FDA as part of a marketing application (for example, as part of an NDA or 510(k)), about which the FDA may require disclosure of financial interest of the clinical investigator in the outcome of the study.