Sec. 811. Clarifying application of exclusive approval, certification, or licensure for drugs designated for rare diseases or conditions
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Section 527 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ) is amended— in subsection (a), in the matter following paragraph (2), by striking same disease or condition and inserting same indication or use for which the Secretary has approved or licensed such drug ; in subsection (b)— in the matter preceding paragraph (1), by striking same rare disease or condition and inserting same indication or use for which the Secretary has approved or licensed such drug ; and in paragraph (1), by striking with the disease or condition for which the drug was designated and inserting for whom the drug is indicated ; and in subsection (c), by striking same rare disease or condition and inserting same indication or use .
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Sec. 811
Clarifying application of exclusive approval, certification, or licensure for drugs designated for rare diseases or conditions
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