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U.S. Code Regulations Constitution Journal Apps
  1. Regulations
    All Titles
  2. title 42
    Public Health
  3. chapter I
    CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. part 11
    PART 11—CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION
  5. subpart D
    Subpart D—Additional Submission of Clinical Trial Information

Subpart D. Subpart D—Additional Submission of Clinical Trial Information

  • § 11.60 - What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products?
  • § 11.62 - What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?
  • § 11.64 - When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
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