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The FDA's Evolving Role in MCM Development

Behind the Scenes in Biosecurity-Video Interviews with Leaders in the Field

February 05, 2014

Speaker: Luciana Borio, MD, Assistant Commissioner for Counterterrorism Policy and Director, Office of Counterterrorism and Emerging Threats in the Office of the Chief Scientist, US Food and Drug Administration

In this interview, Dr. Borio outlines the evolving role that the Food Drug Administration (FDA) has assumed in the development of medical countermeasures. Under Dr. Borio's leadership, the FDA has established the Medical Countermeasure Initiative (MCMi), which is an effort to hasten the development of these products, and to improve their odds of achieving FDA approval. The MCMi has made investments in improving the regulatory science that will be necessary for government's ability to evaluate a new generation of medical products. Here, Dr. Borio discusses some of the successes that the FDA has achieved in this arena, such as the ability to evaluate and approve multiplex diagnostic assays, as well as the challenges that remain.



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