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Real-World Data Or Studies Of Competitor Drugs Can Serve As Confirmatory Evidence For US FDA

 
• By Brenda Sandburg

Draft guidance describes seven types of confirmatory evidence that can be used with one adequate and well-controlled clinical study to demonstrate substantial evidence of effectiveness, including evidence from expanded access, real-world data, and studies of other drugs in the same class.

Clinical trial puzzle
FDA draft guidance specifies what confirmatory evidence can support a single clinical trial • Source: Shutterstock

The US Food and Drug Administration has clarified what evidence sponsors can submit to support approval of a drug that has been studied in a single clinical trial.

The agency's draft guidance, “Demonstrating Substantial Evidence of Effectiveness Based On One Adequate And Well-Controlled Clinical Investigation and Confirmatory...

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