What is a Botanical Drug?
A botanical drug is made of a single plant or mix of plants. FDA considers the entire mixture as the active pharmaceutical ingredient (API) for a botanical drug.
Developing herbal medicines with known safety and efficacy to prescription botanical drugs in the US is an efficient drug development pathway, comparing to the pathway of purifying a single molecular from a plant.
American Botanical Drug Association
Why We Exist?
The FDA “Botanical Drug Development Guidance for Industry" opens doors for botanical products like herbal medicines and cannabis-derived products to develop into prescription drugs. Developing already-known safe and effective herbal medicines through the FDA botanical drug IND process is an efficient drug development pathway ...
Modern herbal medicines come in formats of pills or capsules. Their safety and efficacy have been demonstrated by daily use on a large population. Identifying already known safe and effective herbal medicines with the potential to be developed as US prescription botanical drugs is an efficient drug development pathway...
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