What regulations or guidance documents exist that would help with investigation and development of safe and effective new products that might be used in countering bioterrorism?

In May 2002, the FDA published "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible" [21 CFR 601 Subpart H, as well as 21 CFR 314 Subpart I for New Drugs]. This rule, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions caused by exposure to biological, chemical, radiological, or nuclear substances. This rule amends the new drug and biological product regulations to identify the information needed to provide substantial evidence of the efficacy of new drug and biological products only when human efficacy studies are not ethical and field trials are not feasible. The new rule does not address the need for safety data which still must be established.