FDA EIR - Janssen Biotech, Inc. - November 30, 2018

An FDA surveillance inspection of Janssen Research and Development, LLC, located in Spring House, PA, took place from November 26-30, 2018. This inspection was a high-priority review for a New Drug Application (NDA 212018) for erdafitinib, conducted under the Compliance Program Guidance Manual 7348.810 for Sponsors, Contract Research Organizations, and Monitors. While no formal Form FDA-483 (Inspectional Observations) was issued at the conclusion of the inspection, specific concerns were discussed with the company's management. The main issues identified included an initial failure to provide a comprehensive list of all Contract Research Organizations (CROs) involved in the study, leading to a request for an updated vendor list. Furthermore, deviations were noted in the adherence to study protocols concerning dose interruptions and subject withdrawals due to adverse events. One instance involved a subject continuing treatment despite a Grade 3 adverse event, conflicting with the dose modification plan, though it was documented as a protocol deviation. Another discontinuation based on an investigator's cumulative assessment of Grade 1 and 2 adverse events was deemed acceptable but underscored the need for clarity. The primary actions required were the submission of the complete CRO/vendor list and a renewed emphasis on stringent adherence to study protocols, particularly regarding adverse event management and dose modification strategies, to prevent similar deviations in the future.