21 U.S.C. § 360aa — Recommendations for investigations of drugs for rare diseases or conditions
submitted 88 years ago by Pub. L. 97-414 to r/title-21-FOOD-AND-DRUGS · 210 words · no verdicts yet
The company developing a drug for a disease rare in the United States can ask the Secretary of Health and Human Services for written advice. The Secretary must recommend what non-clinical and clinical studies the drug needs before it can be approved or licensed. The Secretary must also write regulations for how this process works.
(a) Request by sponsor; response by Secretary*
The sponsor of a drug* meant for a disease or condition that is rare in the United States can ask the Secretary for written recommendations. The sponsor wants to know what non-clinical investigations, like lab and animal studies, and what clinical investigations, meaning studies in people, the drug needs before it can be approved under section 355, or, if it is a biological product, licensed under section 262 of title 42.
If the Secretary has reason to believe the drug really is for a disease or condition that is rare in the United States, the Secretary must give the sponsor written recommendations. Those recommendations cover the non-clinical and clinical investigations the Secretary believes, based on the information the Secretary has at the time of the request, would be necessary for approval of the drug for that disease or condition under section 355, or for licensing it under section 262 of title 42.
(b) Regulations
The Secretary must issue regulations laying out the procedures for carrying out subsection (a).
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—
it may be approved for such disease or condition under section 355 of this title, or
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).
Source credit: (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.)
- 1938Enacted · Pub. L. 97-414 · 96 Stat. 2049
- 1985Amended · Pub. L. 99-91 · 99 Stat. 387
- 1997Amended · Pub. L. 105-115 · 111 Stat. 2325, 2326
A history note hasn’t been published yet. The record shows enactment by Pub. L. 97-414 on 1938-06-25.
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