Abbvie

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 for Venclexta submitted by Abbvie

FDA did not post any warning letters this week to Sponsors/Monitors/Contract Research Organizations (CROs), Institutional Review Boards (IRBs) or Clinical Investigators. From the archives, here is the Clinical Inspection Summary for Venclexta submitted by Abbvie. Three sites were selected for inspection, as well as the sponsor. The three sites inspected had participated in both the Phase 1 and Phase 2 studies that were submitted for FDA review. FDA notes that the sites had high enrollment and a strong efficacy effect. Site inspections ranged over three to nine days, and the sponsor inspection took place over two weeks. One site received a 483.

Dr. Wierda was cited for failing to report three serious adverse events (death, pacemaker implant and a hip fracture) to the sponsor within the two day timeframe required by the protocol.