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FDA Cracks Down on ClinicalTrials.gov Reporting Failures

FDA Law Blog

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).

article thumbnail

FDA Cracks Down on ClinicalTrials.gov Reporting Failures

FDA Law Blog

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).