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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER D—DRUGS FOR HUMAN USE
  6. PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION

  • CFR
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  1. Subpart A—General Provisions (§§ 312.1 - 312.10)
  2. Subpart B—Investigational New Drug Application (IND) (§§ 312.20 - 312.38)
  3. Subpart C—Administrative Actions (§§ 312.40 - 312.48)
  4. Subpart D—Responsibilities of Sponsors and Investigators (§§ 312.50 - 312.70)
  5. Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses (§§ 312.80 - 312.88)
  6. Subpart F—Miscellaneous (§§ 312.110 - 312.145)
  7. Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests (§ 312.160)
  8. Subpart H [Reserved]
  9. Subpart I—Expanded Access to Investigational Drugs for Treatment Use (§§ 312.300 - 312.320)
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
Source:
52 FR 8831, Mar. 19, 1987, unless otherwise noted.
Editorial Note:
Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.

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