Covered clinical study

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A covered clinical study is any study of a drug, biological product or device in humans, submitted in a marketing application or reclassification petition. It is relied on by the applicant or Food and Drug Administration (FDA) to establish that the product is effective. Studies that show equivalence to an existing effective product are also acceptable.

It can also refer to any study in which a single investigator makes a significant contribution to the demonstration of safety. In general, however, this does not include pharmacokinetic studies, most clinical pharmacology studies, studies conducted at multiple sites, treatment protocols or parallel track protocols.

An applicant may consult the FDA as to which clinical studies constitute ‘‘covered clinical studies’’, for purposes of complying with financial disclosure requirements.