Perspective: On the Origin of the Animal Rule: New Drug and Biological Drug Products Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethi

| 01 December 2009

"It seems clear that organic beings must be exposed during several generations to new conditions to cause any great amount of variation." While those who deal with government agencies may believe that Charles Darwin's statement, from the opening paragraph of On the Origin of Species, must apply to organizations as well as organic beings, the Food and Drug Administration (FDA) has shown itself to be capable of rapid variation in response to new conditions, at least new conditions of war.


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