### Question
How does DRUGS AND DEVICES define surrogate endpoint?


### Answer
Under *21 U.S.C. § 357*, **surrogate endpoint** is defined as:

> a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—


(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product

#### Citation:
  - *21 U.S.C. § 357*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

