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21 U.S. Code § 360aa

Recommendations for investigations of drugs for rare diseases or conditions

21 U.S. Code § 360aa. Recommendations for investigations of drugs for rare diseases or conditions

(a) Request by sponsor; response by SecretaryThe 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
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