IVRS

FDA Clinical Inspection Summary: Mavyret (glecaprevir/pibrentasavir-ABT-493+ABT-530) submitted by Abbvie

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 Mavyret (glecaprevir/pibrentasavir-ABT-493+ABT-530), submitted by Abbvie. Seven sites were inspected. Inspections ranged from three to seven days. Two sites received FDA Form 483s.

Dr. Jazrawi was cited for:

  • Inadequate documentation to support one subject met inclusion criteria for two lab values

Dr. Zogg was cited for:

  • Lack of documentation to support kit numbers dispensed and returned. (NOTE: FDA notes that the investigator stated that this function was performed by the Interactive Response Technology provider contracted by the sponsor, but FDA still issued the 483 to the site. FDA further notes that the investigator submitted an acceptable corrective action plan.)

FDA Clinical Inspection Summary: Nerlynx (neratinib maleate) submitted by Puma

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 Nerlynx (neratinib maleate) submitted by Puma. Four sites plus the sponsor were inspected. Site inspections ranged from two to five days, and the sponsor inspection lasted 3 days. Two sites received FDA Form 483s.

Dr. Chan was cited for:

  • Failing to maintain accurate investigational product accountability records. FDA notes that at a time when the IVRS system was down, the site called the IVRS helpdesk for a manual assignment over the phone. The kit assigned over the phone differed that a faxed kit number subsequently sent to the site.

Dr. Tomasevic was cited for:

  • Failing to report adverse events that appeared in subject diaries for three subjects. 

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.

FDA Clinical Inspection Summary: Avycaz (Avibactam sodium; ceftazidime)

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 Avycaz (Avibactam sodium; ceftazidime) submitted by Cerexa. Four sites, the sponsor and the CRO were inspected. Site inspections ranged from three to thirteen days and the sponsor inspection took place over fifteen days. The inspection of the CRO was based on problems with the IVRS managed by the CRO during the study. Two sites plus the sponsor received FDA Form 483s.

Dr. Patzan was cited for:

  • Failing to conduct a clinical investigation according to the investigational plan, specifically:
    • Enrolling three subjects who met exclusion criteria
    • Failing to report three adverse events to the sponsor (depression, facial edema and rash)
  • Failure to prepare and maintain adequate and accurate case histories
    • The subject diaries and drug accountability logs for five (of fifteen patients) contained discrepancies.

Dr. Bibi was cited for: 

  • Six subjects were enrolled despite meeting exclusion criteria
  • Two subjects were enrolled without the PI reviewing screening/eligibility laboratory values

The sponsor, Actavis, was cited for:

  • Failing to retain records, specifically:
    • The sponsor failed to retain all shipping records for drug product to eleven clinical sites
    • Failing to retain ten monitoring visit reports
    • Failing to follow the investigational plan, specifically nine monitoring visit reports were not signed off in the required timeframes
  • Failing to ensure proper monitoring of the study
    • The original sponsor of the study did not identify issues with the IVRS system failing to properly allocate drug to 28 of 33 clinical sites