ABSTRACT
On February 5, 2003, the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for the use of pyridostigmine bromide as a pretreatment for poisoning with the nerve agent, soman. This approval was granted under recently adopted regulations that permit the marketing of such treatments on the basis of effectiveness data obtained in animal studies. This chapter will discuss the regulatory and scientific issues raised by these applications generally, as well as those considered for this specific application.
