Speaker Biography
Joseph Famulare
Joseph Famulare is the deputy director, Office of Compliance in the Center for Drug Evaluation and Research. Office of Compliance is composed of the Immediate Office of the director and four divisions which cover new drugs and labeling compliance, manufacturing and product quality and compliance, risk management and surveillance, and the Division of Scientific Investigations. The Office is responsible for a number of drug quality program areas including: addressing public health risks associated with legal violations; developing and overseeing drug compliance programs designed to reduce consumer exposure to risks of unsafe and ineffective drugs; monitoring the quality of human drugs through inspectional coverage, product testing, and other pre- and post-market surveillance activities; developing policies and compliance strategies to ensure that over-the-counter and prescription drugs are of high-quality, properly labeled, safe, pure, and meet applicable drug approval requirements; and developing policy and standards to achieve high product quality through application of current good manufacturing practice requirements. Famulare began his career as an investigator in Newark District in 1977. He subsequently worked as a resident in charge investigator in the Buffalo District and a supervisory investigator in the New York District. Much of his fieldwork has been in the drug cGMP area.