FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the recently posted clinical inspection summary for Calquence (acalabrutinib) submitted by Acerta Pharma. Two sites (out of forty participating in the trial )plus the sponsor were inspected. Site inspections lasted two and five days. Sites were selected on the basis of high enrollment and potential contribution to efficacy. The sponsor inspection lasted two weeks.
The sponsor received a FDA Form 483 for failing to monitor the study properly, specifically:
- Failing to ensure sites submitted protocol amendments to the IRB in a timely fashion. Delays were noted to be four to eleven months.
- Failing to assure investigators and subinvestigators documented training.