high need cure
Defined in 1 dictionary — U.S. Code
United States Code
42 U.S.C. § 287A — in this section (4 versions over time)
The term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21,1 biological product (as that term is defined by section 262(i) 2 of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of the Center—
(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and
(B) for which the incentives of the commercial market are unlikely to result in its adequate or timely development.
42 U.S.C. § 282d — in this section
The term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21,1 biological product (as that term is defined by section 262(i) 2 of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of NIH—
(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and
(B) for which the incentives of the commercial market are unlikely to result in its adequate or timely development.