Sec. 812. Clarifying application of exclusive approval, certification, or licensure for drugs designated for rare diseases or conditions
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/bill/117/hr/7667/eh/section-812·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 approved indication or use within such rare disease or condition ; 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 .
The amendments made by subsection
(a)shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved under section 505 of such Act ( 21 U.S.C. 355 ) or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ).
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Sec. 812
Clarifying application of exclusive approval, certification, or licensure for drugs designated for rare diseases or conditions
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