Covered Clinical Study definition
Covered Clinical Study means any study of a drug or device in humans submitted in a marketing application or reclassification petition subject to this part that the Applicant or Food and Drug Administration (FDA) relies on to establish that the product is effective or any study in which a single Investigator makes a significant contribution to the demonstration of safety.
Covered Clinical Study means any study of a drug or device in humans submitted in a marketing application or reclassification petition subject to this part that the applicant or FDA
Covered Clinical Study means any study of a drug or device in humans submitted in a marketing application or reclassification petition subject to FDA regulations (21 CFR Part 54) that the sponsor or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product) or that make a significant contribution to the demonstration of safety.