The goal of the FDA is to foster the development of vaccines, drugs and diagnostic products, safeguards of the food supply, and other measures needed to respond to bioterrorist threats. New products are needed to diagnose, prevent, and treat public threats, such as smallpox, anthrax, Q fever, and botulinum toxin. The FDA is participating in an interagency group preparing for response in a civilian emergency. In addition, the FDA will be proposing standards for the use of animal efficacy data in approving new products to counter chemical and biological agents. The agency is also participating in setting a broad-based Federal research agenda to facilitate the government’s preparedness against bioterrorism, and is identifying facilities and activities suitable for the production of biological weapons. Also, the agency is involved in product development, review, and testing; and is ensuring that appropriate product surveillance and sponsor compliance are executed in accordance with regulations. The FDA’s regulation of medical products is based on science, law, and public health considerations. Research conducted that is contributing to biological warfare defense and other counterbioterrorism efforts is in the following areas: design of new vaccines; pathogenesis and mechanism of replication of biological warfare agents; new methods and standards to expedite the review of new vaccines and immunoglobulins; and stem cell protection and chemokine/cytokine and angiogenic agent defense mechanisms. Many of the biological warfare defense products pose difficult problems with regard to obtaining clinical efficacy data. For example, human efficacy trials cannot be performed because such studies would involve exposing healthy human volunteers to a lethal agent without proven therapy and field trials. For licensure or other approval, a biological warfare defense product must have an acceptable quality, safety, efficacy, and potency profile. 2 figures, 1 table, and 3 references.