CBER continues to be very active in the President's Countering Bioterrorism Initiative. CBER staff have participated in numerous meetings, briefings, and conferences representing FDA with staff from the Department of Defense, the Department of Health and Human Services (DHHS), and the Office of Management and Budget as well as other DHHS Agencies including the National Institutes of Health and the Centers for Disease Control and Prevention. The Center has also engaged in the development of new regulatory models to accommodate the need for preparedness in the case of an emergency attack. For example, procedures and protocols are being developed to enable the use of investigational new drugs in a highly controlled, safe manner for particular emergency situations, such as responding to a bioterrorist attack that exposed individuals to the agent that causes anthrax. |