biomarker

(1)The term “biomarker”— (A)means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and (B)includes a surrogate endpoint.

Source

21 USC § 357(e)(1)


Scoping language

In this section
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