FDA did not post any warning letters to Sponsors/Monitors/CROs, Clinical Investigators or IRB's this week. From the archives, here is the Clinical Inspection Summary for Tecentriq (Atezolizumab) submitted by Genetech. Three sites (of 62) from the Phase II study that was submitted to FDA were selected for inspection. FDA did not provide information regarding how sites were selected for inspection. Site inspections ranged from three to six days. The sponsor was also inspected over one week. One investigator received a FDA form 483.
Dr. Joseph was cited for:
- One subject was enrolled and received investigational product prior to receiving the confirmatory MRI for eligibility.
- Enrolling another subject prior to confirming adequate organ function.
- Failure to collect pre and post dose vital signs for some subjects.
- Failure to collect required urine samples for analysis.