Lauren N. Howard U.S. FDA

Lauren Howard is the Pre-Approval Manager and Drug Specialist under FDA's Office of Regulatory Affairs, Office of Pharmaceutical Quality Operations, Division III. In this role, she evaluates facilities listed in drug applications in partnership with FDA’s Center for Drug Evaluation and Research (CDER). Lauren began her career with the Agency in 2014 as a drug investigator conducting a wide-range of pharmaceutical inspections both domestically and internationally. She has carried out over 250 complex domestic and international inspections resulting in warning letters, import alerts, recalls, regulatory meetings and injunction. Over the course of her career, she has provided training to ORA drug investigators at various national drug training courses and lectured at numerous external events. Lauren holds a BS in Neuroscience from the University of Cincinnati.