FDA Enforcement Standards

Dr. McClellan talked about the role of the FDA in protecting the public health, and FDA enforcement standards. New challenges facing the FDA included the increasing number and complexity of products, and the threat of terrorism. FDA initiatives included using clear and consistent guidelines, incorporating the latest scientific innovations, pooling resources with other agencies and organizations, and deterring non-compliance through prosecution and punishment. Following prepared remarks, Dr. McClellan responded to questions from the audience.