high need cure
(3) High need cure The term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21 , biological product (as that term is defined by section 262(i) 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.