ఫార్మాస్యూటికల్ రెగ్యులేటరీ వ్యవహారాలు: ఓపెన్ యాక్సెస్

This manuscript has presented evidence for the value of and strategy for the development of Plant (Botanical) preparations as approved drugs (pharmaceuticals). Such preparations have historically been the basis for many (most) traditional medicines but have not usually been developed clinically in such a way as to provide confirmation of their safety and efficacy and importantly their consistency such that they provide predictable clinical outcomes patient to patient and reproducibly over time. We outline the process by which these attributes may be accomplished. There are numerous unmet medical needs where botanical drugs can contribute to their solution.