FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for Uptravi (selexipag) submitted by Actelion. Two trials (301 and 302) were submitted to FDA. Three sites from the 302 study plus the sponsor were chosen for inspection. Site inspections ranged from three to four days. The sponsor inspection lasted four days. Sites were selected for inspection based on high enrollment and high overall efficacy results (as determined by FDA's statistical analysis). One site received a 483.
Dr. Liu was cited for:
- Failing to have three subjects sign an updated informed consent form prior to conducting study related procedures at a study follow up visit.
- FDA notes that there were no updated assessments or additional safety information described in the updated informed consent for one of the three subjects cited in the finding.