FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the drug approval archives, here is the Clinical Inspection Summary for Gilead's Genvoya (elvitegravir; cobicistat; emtricitabine; tenofovir alafenamide). Eight clinical sites were inspected across two clinical studies. Site inspections ranged from three days to two weeks. FDA selected sites based on the following criteria:
1) Enrollment of a relatively large number of subjects with a treatment effect that was greater than average
2) Sites that participated in both pivotal studies as well as participating in the switch study
3) The need to determine if sites conducted the trials ethically and were in compliance with GCP regulation and local requirements.
Two sites received 483s.
Dr. Chetchotisakd received a 483 for:
- Enrolling a subject prior to assessing the genetic testing required for eligibility.
- Enrolling a subject who was not eligible for the trial due to the genetic test results.
Dr. Benson received a 483 for failing to follow the investigational plan, specifically:
- Repeat urinalysis was not conducted as required by protocol for two subjects
- Four subjects experienced adverse events that were not reported per protocol (scattered joint pain, vomiting, lightheadedness, diarrhea)