FDA Clinical Inspection Summary: Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics

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 Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics. Two pivotal studies were submitted. Four sites plus the sponsor were selected for inspection. Site inspections ranged over four to twenty six days. The sponsor inspection took place over four days. Sites were selected for inspection based on participation in both studies, high enrollment, high contribution to efficacy and high rates of serious adverse events on study. Two sites received FDA Form 483s. 

Dr. Hansen was cited for:

  • Failing to document two adverse events in the CRF (facial eczema and injection site reaction)
  • Failing to report one prior therapy per protocol requirements

Dr. Overcash was cited for:

  • Failing to maintain adequate case histories, specifically
    • Failing to properly document adverse events in 34 out of 154 subjects reviewed
    • Failing to properly document the end date of concomitant medications in 4 out of 22 subjects reviewed
    • Failing to properly document medical history in 4 out 22 subjects
  • Failing to conduct the study per the investigational plan
    • Nine out of 154 subjects did not have their study Day 3 photographs taken twelve hours apart