FDA did not post any warning letters this week to Sponsors, Monitors, CROs, IRBs or Clinical Investigators. From the archives, here is the Clinical Inspection summary for Perjeta (pertuzumab) submitted by Roche. Three sites were selected for inspection on the basis of study enrollment. Inspections ran concurrently, lasting 3 to 4 days. One site received an FDA Form 483.
Dr. Bianchi was cited for:
- Failing to maintain adequate drug disposition records
- Two subjects received investigational product from another study (note: the other study was also for pertuzumab)
- On ten occasions over three years, subjects were administered commercial product instead of investigational product due to low inventory at the pharmacy.