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 Tymlos (abaloparatide) submitted by Radius Health. Four sites plus the sponsor were inspected. Sites inspections ranged over 8 to 12 days and the sponsor inspection ranged over 8 days. The sponsor received a FDA Form 483.
Inspection criteria for sites included the following:
- High percentage of screened patients meeting enrollment criteria
- Low rate of non-serious adverse events reported compared to other trial sites
- No history of FDA inspections
- High number of enrolled subjects
- Minimal history of experience as a Principal Investigator
- Rate of missing data within the datasets submitted to FDA
- Location of the site within a non-ICH region
Radius was cited for:
- The transfer of regulatory obligations (TORO) to the Contract Research Organization was not described in writing. Work statement plans for pharmacovigilance, clinical monitoring and clinical study management were not finalized until after the study started.
- Failing to monitor the study properly, specifically three sites began screening patients prior to the monitoring guidelines being finalized and one site randomized a subject prior to being monitored.