Trilogy Writing and Consulting Logo

Glossary Terms

Integrated Summary of Efficacy

A document, unique to regulatory submission for the United States, which evaluates the overall summaries and statistical analyses of the combined efficacy data from the various clinical studies conducted during drug testing. It is submitted to the Food and Drug Administration (FDA) in a New Drug Application (NDA), and included in section 5.3.5.3 of the CTD.

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