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 Pomalyst (pomalidomide) submitted by Celgene. Three sites plus the sponsor were selected for inspection based on the submission of a single Phase 1/2 study. Site inspections ranged from six to twenty days and the sponsor inspection ranged over one month. One site and the sponsor received an FDA Form 483.
Dr. Siegel was cited for failing to maintain adequate investigational product accountability. Specifically, the records for three subjects did had discrepancies of two to five capsules.
Celgene was cited for the following:
- Inadequate monitoring of the study
- The monitoring plan required investigational product accountability to be performed at every visit.
- FDA review of monitoring visit reports determined that for three sites investigational product accountability was done at half or less than half the visits.
- Four monitoring visit reports lacked a description of investigational product accountability activities by the monitor at the visit.
- Investigational product accountability records lacked lot numbers and quantities of investigational product destroyed by a third party.
- Inadequate labeling of investigational product
- The investigational drug labeling lacked directions to the patient to take at least two hours before or after eating.