FDA did not post any warning letters this week to Sponsors/Monitors/CROs, Clinical Investigators or IRBs. From the archives, here is the Clinical Inspection Summary for Rhopressa (netarsudil) submitted by Aerie Pharmaceuticals. Two sites were selected for inspection, based on enrollment and a large number of INDs listing the investigators (27 and 9) and no inspections or no inspections in the last twenty two years. Both sites received FDA Form 483s.
Dr. Cooke was cited for:
- Failing to follow the investigational plan, specifically failing to repeat a test as directed by protocol for three patients
- Assuming lab values were normal when a lab report was not available for one patient's visit
Dr. Logan was cited for:
- Fourteen "transcription deficiencies" across eighteen patients' CRFs
- Five instances of non-serious adverse events and concomitant medications not being captured in the CRF