Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistDr. Konrad Rejdak was cited for violations in conducting a Phase III clinical study of HYQVIA (Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase) for treating Chronic Inflammatory Demyelinating Polyradiculoneuropathy. The inspection under the Bioresearch Monitoring Program identified failure to prepare and maintain adequate and accurate case histories documenting all observations and data for subjects administered the investigational product, in violation of 21 CFR 312.62(b). The violations related to improper conduct and oversight of the clinical research involving investigational biologics products under regulations governing 21 CFR Parts 50, 56, and 312.