FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary of Darzalex (daratumumab), submitted by Janssen Biotech. Three sites plus the sponsor were selected for inspection of the Phase I and Phase 2 studies submitted as part of this BLA. Sites were selected for inspection due to high enrollment and significant contribution to efficacy. In addition, one site was selected due to prior FDA findings when the clinical investigator was at a different clinical site. Site inspection ranged from three to eight days, and the sponsor inspection lasted eight days. One site received a 483.
Dr. Lauder received a 483 for failing to follow the investigational plan, specifically:
- Six out of twenty subjects did not receive the full dose of study drug at the initial infusion. FDA notes that these subjects had the infusions paused and restarted at half the infusion rate due to infusion reactions, and the site's decision to stop the infusion in order to observe subjects for safety reasons prior to the daily closing time of the infusion room.
- One subject received three concomitant medications to treat an adverse event (left eye swelling) that were not recorded on the case report form (CRF).