New Government Report: New Drug Approval

New Drug Approval: FDA’s Consideration of Evidence from Certain Clinical Trials
by Marcia Crosse
Paperback, 38 pages, 2010, $30.00
ISBN: 9781437938586

“Before approving a new drug, the FDA assesses a drug’s effectiveness. To do so, it examines information 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.”

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