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Regulations last checked for updates: May 23, 2025

Title 42 - Public Health last revised: May 16, 2025
All TitlesTitle 42Chapter IPart 11Subpart 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?
authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b)
source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.
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