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 Bictarvy submitted by Gilead. Five sites were selected for inspection based on treatment effect, financial disclosure and prior inspection history. One site received a FDA Form 483.
Dr. Charest was cited for:
- Failing to provide a participant with an updated consent form. FDA notes that the participant was provided with a consent form for a different study and notes that procedures performed on Week 60 and Week 72 were performed without appropriate consent.