Dr Feigal is a Partner in NDA Partners. He held senior positions in all three FDA medical product Centers including service as the Center Director of CDRH, the Deputy Center Director, CBER and Director of the Office of Drug Evaluation IV (Anti-infective-Antiviral Drug Products), CDER. He has a detailed understanding of the relationship between scientific evidence and regulatory strategy in product development. Before joining FDA, Dr. Feigal was an Associate Professor at the University of California, San Diego, in the Department of Medicine and is trained as a Clinical Epidemiologist. He has also served as the Senior Vice President for Global Regulatory and Global Safety at Élan Pharmaceutical and the Vice President for Global Regulatory at Amgen. He has broad experience assisting companies develop regulatory and safety strategies and interacting with FDA and the EMA for pharmaceutical products and medical devices.