FDA inspection summary for Cresemba by Astellas

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 Cresemba, submitted by Astellas. FDA inspected five clinical investigators for the pivotal studies. These sites were targeted for inspection due to 1) enrollment of a relatively large number of subjects with a treatment effect that was greater than average submitted to these original NDAs (two trials) for a 2-NME drug regimen. Inspections focused on if sites conducted the trial ethically and were in compliance with GCP and local regulations. Although the inspection summary notes that regulatory violations were noted at most of the sites, only one site received a 483. 

Dr. Raad was cited for:

  • Failure to report adverse events
    • Three adverse events for one subject (respiratory failure, sepsis and elevated ST segment) were not reported to the IRB
    • Adverse events for three subjects (death, confusion, multiorgan failure and hyperbilirubinemia) were not reported to the IRB
  • Failure to maintain adequate and accurate records
    • Lack of training documentation for staff
    • One subject did not meet inclusion criteria
    • FDA notes that medical records were difficult to read and review