Federal (United States) · Regulations
Subpart D — Additional Submission of Clinical Trial Information
3 sections
3 sections
- 42 C.F.R. § 11.60What 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 C.F.R. § 11.62What 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 C.F.R. § 11.64When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?