21 U.S.C. § 360aa
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§ 360aa. Recommendations for investigations of drugs for rare diseases or conditions
- (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—
- (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 .
- (b) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
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