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Efficacy Supplement Approvals | FDA

https://www.fda.gov/drugs/nda-and-bla-approvals/efficacy-supplement-ap...

Entity (NME) Drug and New Biologic Approvals Priority NDA and BLA Approvals Efficacy Supplement Approvals NDA and

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Efficacy

Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as effectiveness, and it has often been used synonymously, although in pharmacology a distinction is now often made between efficacy and effectiveness. The word efficacy is used in pharmacology and medicine to refer both to the maximum response achievable from a pharmaceutical drug in research settings, and to the capacity for sufficient therapeutic effect or beneficial change in clinical settings.