FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inpsection Summary for Netspot (Gallium dotatate for injection) submitted by Advanced Accelerator Applications USA. One GCP inspection was conducted of the sole participating study and the FDA determined that Official action was warranted.
Dr. Walker was cited for:
- Failure to complete lab testing for several subjects as required by protocol
- Failing to provide Day 1 subject safety exams as required by the protocol for several subjects
- Failing to perform follow up phone calls as required by the protocol for twenty subjects
The FDA noted that for seventeen subjects at site, the imaging review produced discordant results in seventeen subjects.