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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i4
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 312
    PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

Part 312. PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

  • SUBPART A [§ 312.1 - § 312.10] - Subpart A—General Provisions
  • SUBPART B [§ 312.20 - § 312.38] - Subpart B—Investigational New Drug Application (IND)
  • SUBPART C [§ 312.40 - § 312.48] - Subpart C—Administrative Actions
  • SUBPART D [§ 312.50 - § 312.70] - Subpart D—Responsibilities of Sponsors and Investigators
  • SUBPART E [§ 312.80 - § 312.88] - Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
  • SUBPART F [§ 312.110 - § 312.145] - Subpart F—Miscellaneous
  • SUBPART G [§ 312.160 - § 312.160] - Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
  • SUBPART H - Subpart H [Reserved]
  • SUBPART I [§ 312.300 - § 312.320] - Subpart I—Expanded Access to Investigational Drugs for Treatment Use
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