Title 42

PART 11 SUBPART D

Subpart D - Additional Submission of Clinical Trial Information

• 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).
• 81 FR 65138, Sept. 21, 2016, unless otherwise noted.

42:1.0.1.1.12.4.1.1	SECTION 11.60	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
42:1.0.1.1.12.4.1.2	SECTION 11.62	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
42:1.0.1.1.12.4.1.3	SECTION 11.64	11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected

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