FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary submitted for Dupixnet (dupilumab) submitted by Regeneron Pharmaceuticals, Inc. Three sites plus the sponsor were inspected. Sites were selected based on enrollment. Site inspections ranged from four to eight days and the sponsor inspection took place over three days. One site received a FDA Form 483.
Dr. Brunig was cited for failing to consent subjects properly, specifically:
- The original consent form was missing for one subject during the inspection. (FDA notes that a copy was submitted after the inspection.)
- A consent form for one subject for the pharmacogenomics substudy was signed twenty one days after the pharmacogenomics sample was collected.
- One subject backdated a consent form.