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.

Use our tool to look up the definition of terms in our glossary.