FDA Clinical Inspection Summary: ibrutinib submitted by Pharmacyclics

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 ibrutinib submitted by Pharmacyclics. FDA selected three sites for inspection, based on enrollment, treatment effect and higher rates of serious adverse events (SAEs). Site inspections ranged from three to eight days. The sponsor was inspected over 2.5 weeks. The sponsor received a FDA form 483.

Pharmacyclics was cited for failure to monitor the study properly, specifically:

  • Failing to note that Financial Disclosures for two subinvestigators had  signatures on them that did not match the subinvestigator signatures on other documents 
  • Failing to ensure that two subinvestigators listed on the FDA Form 1572 completed Financial Disclosure Forms