Posted by Michael Wonder on 13 Nov 2021
Strengthening the FDA’s enforcement of ClinicalTrials.gov reporting requirements
12 November 2021 - On 28 April 2021, the US FDA announced that it “issued its first Notice of Non-compliance to Acceleron Pharma for failing to submit required summary results information to ClinicalTrials.gov.”
These results were based on a phase 2 trial that reached its primary completion date in June 2017.
The trial examined the safety and efficacy of the candidate drug dalantercept in combination with an FDA approved drug, axitinib, in patients with advanced renal cell carcinoma.
