date:Mar 27, 2013
a biological product when the results of well-controlled animal studies demonstrate that the product is reasonably likely to be effective, in addition to establishing safety in humans. This is the first approval of a plasma derivative using the Animal Rule.
The safety of the product was tested in 40 healthy human volunteers and also monitored in 228 patients who received the antitoxin experimentally under a botulism treatment program administered by the Centers for Disease Control and Preventi