20/21 April 2021
In August 2015, the FDA has published a draft of the guideline "Botanical Drug Development". This guideline addresses issues arising from the particular nature of herbal medicinal products. After its finalization it is supposed to replace the previous guideline from June 2004.
The general approach in the development of herbal medicinal products remained unchanged since 2004. But due to the better understanding of herbal medicinal products and the experience gained during the review of the approval documents for herbals (NDAs/New Drug Applications and INDs/Investigational New Drug Applications), specific recommendations could be adjusted. Still, new sections will be supplemented to better address the late development phase.
The draft guideline also covers the following topics:
For further information please see the full FDA document 'Botanical Drug Development'.