surrogate endpoint

(9)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 withsection 356(c) of this title.

Source

21 USC § 357(e)(9)


Scoping language

In this section
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