FDA EIR - Regeneron Pharmaceuticals Inc - December 21, 2020

An FDA inspection of Regeneron Pharmaceuticals, Inc., located in Tarrytown, NY, was conducted from December 14 to December 21, 2020. This high-priority inspection was initiated by the Center for Drug Evaluation and Research (CDER) under the Prescription Drug User Fee (PDUFA) program, adhering to Compliance Program 7348.810 for Sponsors, Contract Research Organizations, and Monitors. The inspection focused on the company's conduct of clinical studies R1500-CL-1629 and R1500-CL-1719, involving the investigational product Evinacumab, which is regulated as a drug under the Food, Drug, and Cosmetic Act in support of BLA 761181 (IND 116398). The inspection covered a broad scope, including contracts, plans, and standard operating procedures related to contract research organizations, clinical investigators, site qualification, training, investigational product management, electronic data capture systems, quality assurance, safety reporting processes, protocol deviation management, and electronic Trial Master File monitoring reports. Crucially, the inspection concluded without any objectionable observations. Consequently, no Form FDA-483, "Inspectional Observations," was issued to Regeneron Pharmaceuticals, Inc. No samples were collected, and no refusals were encountered, indicating that no immediate regulatory actions were required from the company based on this report. The report will be submitted to CDER for final classification.