Title 21, Food and DrugsRelease 119-102
§360dd Open Protocols for Investigations of Drugs for Rare Diseases or Conditions
Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part B — Drugs for Rare Diseases or Conditions › § 360dd
Summary
If a drug has rare-disease status under 360bb and a 355(i) exemption is filed, the Secretary must encourage the sponsor to design trials that include patients who need the drug and lack effective alternatives.
Full Legal Text
Title 21, §360dd
Food and Drugs, Source: USLM XML via OLRC
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.
Reference
Citations & Metadata
Citation
21 U.S.C. § 360dd
Title 21, Food and Drugs
Last Updated
Aug 21, 2026
Release point: 119-102