FDA Clinical Inspection Summary: Varithena (Polydocanol Injectable Microfoam) submitted by BTG International

FDA did not post any warning letters to Sponsors/Monnitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary for Varithena (polydocanol injectable microfoam) submitted by BTG. Five sites were selected for inspection, based on enrollment, contribution to treatment efficacy, number of protocol deviations, number of subject discontinuations and number of subjects excluded from the statistical analysis. Site inspections ranged over four days to one month. Three sites received a FDA Form 483.

Dr. Deck was cited for:

  • Failing to ensure proper entry of information into the IVRS system. Three subjects had incorrect assessment scores entered into the IVRS. FDA notes that these protocol deviations were entered late, and therefore were not reflected in the line listings that the FDA inspector had.

Dr. Ferris was cited for:

  • Failing to follow the investigational plan, specifically:
    • Six subjects received e-diaries before inclusion/exclusion criteria review was complete.
    • One subject was treated before review of inclusion/exclusion criteria was complete.

Dr. Stanbro was cited for:

  • Failing to follow the investigational plan, specifically:
    • All subjects were provided with an e-diary before screening procedures were complete.
    • Entering IVRS data at randomization instead of at baseline.