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 for Anoro Ellipta submitted by GSK. Two sites were inspected based on enrollment, efficacy and dropout rate. Inspections ranged over four to five days. One site received an FDA form 483.
Dr. Sonne was cited for:
- Failing to specify in source records the identity of the person recording the information
- Including post-it notes in source records, specifying the withdrawal of consent of one subject and medication changes for another subject