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Regulations last checked for updates: May 23, 2025
Title 42 - Public Health last revised: May 16, 2025
All Titles
Title 42
Chapter I
Part 11
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?
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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