FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for Otezla (apremilast) by Celgene. Three sites were selected due to high enrollment, relatively high percentage of treatment responders and randomization irregularities. Site inspections lasted ranged from four to eight days. One site received an FDA form 483.
Dr. Wasel was cited for failing to reconsent subjects to an updated informed consent form at their next visit. FDA also noted that only one study coordinator had access to an electronic system called Sitepad and Studyworks for recording investigator assessments, and appears to note that the investigator should have had access to this electronic data as well.