FDA EIR - REATA PHARMACEUTICALS - July 13, 2021

An FDA inspection of Reata Pharmaceuticals in Plano, TX, was conducted from July 7-13, 2021. This preannounced inspection, part of a Prescription Drug User Fee Act (PDUFA) review for an original New Drug Application, was overseen by the Center for Drug Evaluation and Research (CDER) under Compliance Program 7348.810 for Sponsors. The primary objective was to verify the integrity of data submitted for an NDA, specifically concerning study protocol 43USH1501 ("A Phase 2/3 Trial For The Efficacy and Safety Of Bardoxolone Methyl In Patients with Alport Syndrome"). The inspection also assessed Reata's adherence to FDA regulations regarding the selection and monitoring of clinical investigators, monitoring procedures, adverse event reporting, test article accountability, and data handling. The review encompassed various records, including clinical trial agreements, financial disclosures, IRB approvals, training, and standard operating procedures. Notably, the inspection concluded with no significant objectionable conditions or practices identified. Consequently, no FDA Form 483 was issued, indicating full compliance with the regulatory requirements examined. No specific corrective actions were required from Reata Pharmaceuticals at the conclusion of this inspection. The final compliance determination rests with CDER.