surrogate endpoint

Defined in 1 dictionary — U.S. Code

United States Code

21 U.S.C. § 357 — in this section (4 versions over time)

The term “surrogate endpoint” means 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; or

(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 356(c) of this title.