Countering Bioterrorism

The President's initiative on Countering Bioterrorism is comprised of a number of essential elements for which CBER plays an integral role. One such element is the expeditious development and licensing of products to diagnose, treat or prevent disease following exposure to pathogens that have been identified as bioterrorist agents. These products must be reviewed and approved prior to the large-scale productions necessary to create and maintain a stockpile. Staff must guide the products through the regulatory process, including the manufacturing process, pre-clinical testing, clinical trials, and the licensing and approval process. Experts in these areas are needed to expedite the licensing and approval process for these products. This process is extremely complex and early involvement by staff is crucial to the success of the expedited review process.

Preparedness for and response to an attack involving biological agents are complicated by the large number of potential agents (most of which are rarely encountered naturally), their sometimes long incubation periods and consequent delayed onset of disease, and their potential for secondary transmission. In addition to naturally occurring pathogens, agents used by bioterrorists may be genetically engineered to resist current therapies and evade vaccine-induced immunity. Pathogens that have been identified as potential biological warfare agents include those that cause smallpox, anthrax, plague, botulism, tularemia, and hemorrhagic fevers.


Bioterrorism Act of 2002

Countering Bioterrorism Frequently Asked Questions (FAQs)

Guidance: Emergency Use Authorization of Medical Products

Security Resource Sheet For Manufacturers of Biological Products


Updated: July 31, 2007