. "Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers." Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press, 2010.
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report
in the development and US and global registration of many products and in improving Wyeth’s compliance posture. He also successfully navigated the company through an FDA consent degree. During those 8 years—as a member of many Wyeth governance councils and committees, including the executive-licensing, capitol-expenditure, and commercial councils—he participated broadly and in depth in analyzing the complex business forces driving industry.
Before joining Wyeth, Dr. Burlington served in FDA for 17 years. He was the first physician named as director at of the Center for Devices and Radiological Health (CDRH), where he led major changes, increased the rigor of clinical investigation of medical devices, and championed innovations in the center’s work with industry. Before that, he was a research immunologist and then a manager in the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research (CDER). In those centers, he had responsibility for viral vaccines, investigational biologics, review of biologic license applications, approval of new drug applications, and generic drugs. As medical deputy director in CDER, he also oversaw policy and compliance decisions related to pharmaceuticals.
David W. Feigal, Jr., MD, MPH, is the vice president for global regulatory affairs in Amgen in Thousand Oaks, California. His career in the development of medical therapeutics began with training as a physician epidemiologist with an MD from Stanford University and an MPH from the University of California, Berkeley. He did his internal-medicine residency training at the University of California, Davis and a fellowship in clinical epidemiology at the University of California, San Francisco (UCSF). He joined the UCSF School of Medicine faculty in 1984 with joint appointments in the Department of Medicine and the Department of Epidemiology and Biostatistics and in 1989 moved to the Department of Medicine of the University of California, San Diego.
Dr. Feigal came to the Food and Drug Administration (FDA) in 1992 and headed the Center for Drug Evaluation and Research Antiviral Drug Division, the Anti-Infective Drug Division, and ODE IV. In fall 1997, he moved to the Center for Biologics Evaluation and Research as medical deputy director. In spring 1999, Dr. Feigal became the director of the Center for Devices and Radiological Health (CDRH). At CDRH, he was an advocate for the center’s science and education programs and worked with Congress and industry to launch a medical devices user fee. In 2004, he left FDA to join a regulatory consulting group, NDA Partners, LLP, and resume teaching as a faculty associate at the Sandra Day O’Connor Law School of Arizona State University. In 2006, he joined Élan Pharmaceuticals in South San Francisco as senior vice president for global regulatory and global safety