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 Soliqua (Insulin Glargine/lixisenatide) submitted by Sanofi-Aventis. FDA used the OSI selection algorithm to select sites for inspections, with preference given to sites that had enrolled in both pivotal studies and had never been inspected by FDA. Site inspections ranged from seven to nine days. One site received an FDA Form 483.
Dr. Larsen was cited for failure to follow the investigational plan, specifically:
- Enrolling a subject whose fasting blood glucose level met exclusion criteria
- Enrolling a subject who did not meet inclusion criteria at screening. (Note: The site had attempted to contact the study medical monitor regarding this subject and waited eight days before enrolling the subject. The medical monitor responded three days after subject enrollment, stating that the subject was ineligible.)
- Enrolling a subject who had not performed the required seven point glucose self monitoring required by the protocol.