drug development tool
Defined in 1 place of the United States Code.
The term "drug development tool" includes—
(A) a biomarker;
(B) a clinical outcome assessment; and
(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.
Source
- 2016–present21 U.S.C. § 357Food and Drugs · Repealed. Pub. L. 105115, title I, 125(b)(1), Nov. 21, 1997, 111 Stat. 2325 · in this section