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U.S. Code Regulations Constitution Journal Apps
  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
  5. subpart C
    Subpart C—Administrative Actions

Subpart C. Subpart C—Administrative Actions

  • § 312.40 - General requirements for use of an investigational new drug in a clinical investigation.
  • § 312.41 - Comment and advice on an IND.
  • § 312.42 - Clinical holds and requests for modification.
  • § 312.44 - Termination.
  • § 312.45 - Inactive status.
  • § 312.47 - Meetings.
  • § 312.48 - Dispute resolution.
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