Code · BILL · 116th Congress · H.R. 19 (Introduced in House) — To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the... · Sec. 392

Sec. 392. Orphan drug clarification

83 words·~1 min read·/bill/116/hr/19/ih/section-392

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Section 527(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc(c) ) is amended by adding at the end the following: This subsection applies to any drug designated under section 526 for which an application was approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act after the date of enactment of the FDA Reauthorization Act of 2017, regardless of the date on which such drug was designated under section 526. .

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U.S. Code

Protection for drugs for rare diseases or conditions
§ 360cc

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Sec. 392

Orphan drug clarification

U.S.C.§ 360cc

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