The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—
(1) it may be approved for such disease or condition under section 355 of this title, or
(2) if the drug is a biological product, it may be licensed for such disease or condition under section 262 of title 42.
If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under section 355 of this title or licensing of such drug for such disease or condition under section 262 of title 42.
The Secretary shall by regulation promulgate procedures for the implementation of subsection (a) of this section.
(June 25, 1938, ch. 675, §525, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99–91, §3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105–115, title I, §125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326.)
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