FDA did not post any warning letters this week to Sponsors/Monitors/Contract Research Organizations (CROs), Institutional Review Boards (IRBs) or Clinical Investigators. From the archives, here is the Clinical Inspection Summary for Venclexta submitted by Abbvie. Three sites were selected for inspection, as well as the sponsor. The three sites inspected had participated in both the Phase 1 and Phase 2 studies that were submitted for FDA review. FDA notes that the sites had high enrollment and a strong efficacy effect. Site inspections ranged over three to nine days, and the sponsor inspection took place over two weeks. One site received a 483.
Dr. Wierda was cited for failing to report three serious adverse events (death, pacemaker implant and a hip fracture) to the sponsor within the two day timeframe required by the protocol.