Public Health Emergency - Leading a Nation Prepared
Project BioShield was established to help incentivize private industry to develop vitally needed medical countermeasures by providing multi-year funding to support advanced research, clinical development, manufacture and procurement. Without this secure source of funding, companies do not have the incentive needed to develop the medical countermeasures that are critical to national security.The Project BioShield Act was signed into law on July 21, 2004. Since its inception, the Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response has managed the program and worked to develop the strong partnerships, clear direction, and market incentives needed to make the program a success. Project BioShield funding is used to address national security threats as identified by the Department of Homeland Security’s Material Threat Determination process.
Over the last seventeen years, BARDA cultivated partnerships with partners in government as well as biotechnology and pharmaceutical companies to build a portfolio of cutting edge medical countermeasures that address some of our most pressing health security threats, including anthrax, botulism, Ebola, smallpox, nerve agents, radiation, thermal or radiation burns, and antimicrobial resistance. Many of the products that have been supported under Project BioShield also received advanced research and development funding from BARDA.
supported under ProjectBioshield
added to the Strategic NationalStockpile
licensed or approved by theU.S. Food and Drug Administration
Since 2004, Congress has authorized multiyear funding to support Project BioShield. These funds may be used for advanced research, clinical development, manufacture and procurement of medical countermeasures. Products may be purchased under Project BioShield if they are licensed, approved or cleared by the U.S. Food and Drug Administration, or if they may be made available under an
Emergency Use Authorization during a public health emergency.
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