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Glossary Terms

Summary of Clinical Efficacy

A summary of data relevant to the efficacy of a drug in the intended population for the indication. The summary includes a brief overview of the design of the studies that were conducted to evaluate the efficacy, a tabular listing of all studies that provided information relevant to product efficacy, as well as a comparison and analyses of efficacy results across studies. The Summary of Clinical Efficacy forms section 2.7.3 of the CTD.

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