FEDERAL · 21 U.S.C. · Chapter SUBCHAPTER V—DRUGS AND DEVICES
§360dd. Open protocols for investigations of drugs for rare diseases or conditions
21 U.S.C. § §360dd. Open protocols for investigation
This text of 21 U.S.C. § §360dd. Open protocols for investigation (§360dd. Open protocols for investigations of drugs for rare diseases or conditions) is published on Counsel Stack Legal Research, covering United States primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
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21 U.S.C. § §360dd. Open protocols for investigation.
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.
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History
(June 25, 1938, ch. 675, §528, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2051.)
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21 U.S.C. § §360dd. Open protocols for investigation, Counsel Stack Legal Research, https://law.counselstack.com/usc/21/§360dd. Open protocols for investigation.