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21 U.S.C. · Food and Drugs
21 U.S.C. § 360dd

Open protocols for investigations of drugs for rare diseases or conditions

Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 U.S.C. ● ACTIVE Primary Source Ch. 9
Statutory Text

21 U.S.C. § 360dd — Open protocols for investigations of drugs for rare diseases or conditions

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part B - Drugs for Rare Diseases or Conditions Sec. 360dd - Open protocols for investigations of drugs for rare diseases or conditions From the U.S. Government Publishing Office, www.gpo.gov

§360dd. Open protocols for investigations of drugs for rare diseases or conditions

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.

(June 25, 1938, ch. 675, §528, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2051.)

Source: uscode.house.gov — public domain Official Source ↗
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◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-USC21-SEC-287251
Entity Class
STATUTE / FEDERAL-CODE-SECTION
Domain Signature
boisestandard.org
Citation
21 U.S.C. § 360dd
Jurisdiction
Federal — United States
Status
✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
Content Hash
eb03ae97d1ce7633...
Semantic Edges
Pending — corpus passes queued
The statutory text of 21 U.S.C. § 360dd is reproduced from the official United States Code as published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov).
Navigate Corpus — Title 21
← 21 U.S.C. § 360cc 21 U.S.C. § 360ee →
Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S.C. § 30121 U.S.C. § 32121 U.S.C. § 321a21 U.S.C. § 321b21 U.S.C. § 321c21 U.S.C. § 321d21 U.S.C. § 33121 U.S.C. § 33221 U.S.C. § 33321 U.S.C. § 333a21 U.S.C. § 33421 U.S.C. § 33521 U.S.C. § 335a21 U.S.C. § 335b21 U.S.C. § 335c21 U.S.C. § 33621 U.S.C. § 33721 U.S.C. § 337a21 U.S.C. § 34121 U.S.C. § 34221 U.S.C. § 34321 U.S.C. § 343121 U.S.C. § 343221 U.S.C. § 343321 U.S.C. § 343a21 U.S.C. § 34421 U.S.C. § 34521 U.S.C. § 34621 U.S.C. § 346a21 U.S.C. § 346b
21 U.S.C. — public domain ← All Legislation
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boisestandard.org → United States → Law → U.S. Code → Title 21 → 21 U.S.C. § 360dd