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 Alecensa (alectinib hydrochloride) submitted for priority review by Hoffmann-LaRoche. Two clinical sites from the pivotal studies were selected for inspection, as well as the sponsor. The inspections ranged from one week to one month. One site received a 483.
Dr. Ou received a 483 for failing to follow the investigational plan, specifically:
- Enrolling three subjects who did not meet inclusion criteria (history of gallbladder surgery and adequate renal function by serum creatinine clearance)
- Two subjects did not have all screening laboratory procedures performed
- One SAE (hospitalization for bronchitis) was not reported to the sponsor within 24 hours of awareness
- Two subjects did not have all required laboratory assessments while enrolled in the trial
- Two subjects did not have all required vital signs taken at study visits