Botanicals as Drugs A U.S. Perspective

But botanicals do not fit easily into this development paradigm. As a drug class, botanicals have no rival for their structural complexicity or diversity of effects. Defined by their heterogeneity, botanicals have multiple 

Therefore, to be marketed as a pharmaceutical, a botanical must traverse the modern regulatory process resulting in an approved NDA. The fact that no botanical is currently NDA-approved has caused many to speculate whether a botanical could ever make it through the rigorous U.S. drug development process, and still others to ask why one would choose to pursue this avenue, given the panoply of regulatory options already available to botanicals in the United States. 

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