21 U.S.C. § 360dd
Open protocols for investigations of drugs for rare diseases or conditions
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 360dd, Open protocols for investigations of drugs for rare diseases or conditions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454294
- Permanent ID
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Full text
If a drug is designated under section 360bb of this title as a drug for a rare disease or condition and if notice of a claimed exemption under section 355(i) of this title or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.
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.
- Orphan Drug ActHouse: no recorded tallySenate: no recorded tally