FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, let's review the clinical inspection summary for Odomzo submitted by Novartis. Two sites and two imaging CROs (one for radiology images and one for photographs) from the study were inspected. Sites were selected on the basis of enrollment and primary efficacy results. Dr. Gibney was also selected by FDA due to a large number of protocol deviations for not performing required assessments. Site inspections were conducted over a period of eleven days for one site, and six weeks for Dr. Gibney's site.
Dr. Gibney received a 483 for failing to follow the investigational plan, specifically:
Six of sixteen subjects did not have urinalysis performed by the method specified in the protocol. FDA notes that the sponsor and IRB were aware of this deviation.
Three subjects were missing protocol required photographs at one visit. FDA notes that the imaging system noted these photos were missing and that the investigator was preparing to report this to the IRB.
FDA also notes that there were two SAEs at this site that were reported late, and after the data cut-off for the NDA; however, this item was not included in the 483 issues to the site.