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- Covered_clinical_study abstract "In drug development, a covered clinical study refers to a clinical study, submitted to the Food and Drug Administration (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. For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation. The FDA defines a covered study as "...any study of a drug, biological product or device in humans submitted in a marketing application or reclassification petition that the applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product) or any study in which a single investigator makes a significant contribution to the demonstration of safety."".
- Covered_clinical_study wikiPageID "1983973".
- Covered_clinical_study wikiPageRevisionID "553376827".
- Covered_clinical_study hasPhotoCollection Covered_clinical_study.
- Covered_clinical_study subject Category:Clinical_research.
- Covered_clinical_study subject Category:Food_and_Drug_Administration.
- Covered_clinical_study comment "In drug development, a covered clinical study refers to a clinical study, submitted to the Food and Drug Administration (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. For example, the applicant must disclose whether an investigator owns equity in the sponsor, or owns proprietary interest in the product under investigation.".
- Covered_clinical_study label "Covered clinical study".
- Covered_clinical_study sameAs m.06bx22.
- Covered_clinical_study sameAs Q5179236.
- Covered_clinical_study sameAs Q5179236.
- Covered_clinical_study wasDerivedFrom Covered_clinical_study?oldid=553376827.
- Covered_clinical_study isPrimaryTopicOf Covered_clinical_study.