Sec. 3015. Amendments to the Orphan Drug grants
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/bill/114/hr/34/enr/section-3015·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 5 of the Orphan Drug Act ( 21 U.S.C. 360ee ) is amended— in subsection (a), by striking paragraph
(1)and inserting the following:
(1)defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses, ; and in subsection (b)(1)— in subparagraph (A)(ii), by striking “and” after the semicolon; in subparagraph (B), by striking the period and inserting “; and”; and by adding at the end the following: prospectively planned and designed observational studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition and in the development of a therapy, including studies and analyses to— develop or validate a drug development tool related to a rare disease or condition; or understand the full spectrum of the disease manifestations, including describing genotypic and phenotypic variability and identifying and defining distinct subpopulations affected by a rare disease or condition. .
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Sec. 3015
Amendments to the Orphan Drug grants
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