FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the clinical inspection summary for Belinostat submitted by Spectrum Pharms. Two sites plus the sponsor were inspected. One site inspection lasted three days, the sponsor inspection lasted four days and the site inspection that resulted in a FDA Form 483 took place over seven (7) weeks.
Dr. Shustov was cited for failing to follow the investigational plan, specifically:
- Reporting a Serious Adverse Event (SAE) eight days late
- Administering another therapeutic agent before completing all end of treatment assessments for four subjects
- Failing to follow withdrawn subjects for thirty days in order to assess adverse events