FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the recent Clinical Inspection Summary for Beponsa (Inotumuzab ozogamicin) submitted by Wyeth. Three sites were selected for inspection. Inspections ranged over 5 to 7 days. Once site received a FDA Form 483.
Dr. Kantarjian was cited for failing to properly consent a patient, specifically:
- The patient had noted dated the informed consent form prior to initiating investigational therapy. A properly executed consent form was not obtained until one week later.