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New Drug Approval: FDA’s Consideration of Evidence from Certain Clinical Trials
Before approving a new drug, the FDA assesses a drug's effectiveness. To do so, it examines info. contained in a new drug application (NDA), including data from clinical trials in humans. Several types of trials may be used to gather this evidence. Non-inferiority trials aim to demonstrate that the difference between the effectiveness of a new drug and an active control is small enough to show that the new drug is also effective. FDA has issued guidance on these trials. This report: (1) identifies NDAs for new molecular entities -- potentially innovative new drugs not FDA-approved in any form -- that included evidence from non-inferiority trials; (2) examines the characteristics of these trials; and (3) describes FDA's guidance on these trials. Illustrations.
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