21 U.S.C. § 360ff–1
Targeted drugs for rare diseases
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 360ff–1, Targeted drugs for rare diseases, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454298
- Permanent ID
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Full text
The purpose of this section, through the approach provided for in subsection (b), is to—
The Secretary may, consistent with applicable standards for approval under this chapter or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act for a genetically targeted drug or a variant protein targeted drug to rely upon data and information—
For purposes of this section—
the term “genetically targeted drug” means a drug that—
the term “variant protein targeted drug” means a drug that—
Nothing in this section shall be construed to—
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- 21st Century Cures ActHouse: no recorded tallySenate: no recorded tally