Executive Agencies

Investigational New Drugs for Health Protection is responsible for executing DoD policy pertaining to the preventive or therapeutic use during military operations of investigational drug or biological products in those cases where no appropriate FDA approved product is available. This includes the development, in coordination with ASD(HA) and the involved CINC, of a treatment protocol for use of the investigational product; the review of protocols by The Surgeon General's Human Subjects Research Review Board, and Congressional and public notification of the use of the investigational product. In addition, implementation plans for the use of investigational drugs are required to assist the CINC in translating protocol specific requirements into operational actions.