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 Zydelig (idelalisib) submitted by Gilead. Two sites in the submitted study were selected for inspection due to large numbers of study subjects and treatment responders. One site inspection lasted three days and the other site inspection ranged over one month. The sponsor was also inspected in an inspection that ranged over one month. One site and the sponsor received an FDA Form 483.
Dr. Gopal was cited for failing to follow the investigational plan, specifically:
- Failing to follow drug dispensing procedures in that study drug that had been returned from one subject was redispensed to another subject.
- Returned study drug was disposed of prior to the monitoring verifying the returned amounts. FDA notes that in order to determine if this finding was systemic, the FDA required the sponsor to assess and report all instances in the study where study drug was destroyed prior to monitor confirmation of number of tablets returned.
- One Serious Adverse Event (SAE) of febrile neutropenia was not reported within protocol specified timelines. (Note: The SAE was reported within three days.)
Gilead was cited for:
- The monitor for site 121 did not ensure completion of the site delegation of authority log and training log until the end of the trial. (Note: FDA did not cite site 121 for this issue when site 121 was inspected.)