What is a Botanical Drug?
A botanical drug is composed of either a single plant or a blend of multiple plants. According to the US FDA, the entire combination is regarded as the active pharmaceutical ingredient (API) for a botanical drug.
Developing herbal medicines with established safety and effectiveness into prescription botanical drugs in the US is an efficient drug development route, comparing to the process of isolating a single molecular from a plant.
American Botanical Drug Association
Why We Exist?
The FDA's “Botanical Drug Development Guidance for Industry" paves the way for botanical products such as herbal medicines and cannabis-derived products to evolve into prescription drugs. Utilizing the FDA botanical drug IND process to develop herbal medicines with established safety and effectiveness is a streamlined approach to drug development ...
Modern herbal medicines are typically available in pill or capsule formats. These products have already shown their safety and effectiveness through extensive daily use by a significant population. Identifying herbal medicines with established safety and effectiveness that have the potential to be developed into prescription botanical drugs in the United States represents an efficient drug development pathway ...
SVP, United Kingdom
Botanical Drug Impact Fund
SVP, Scientific Affairs
VP, India Central
SVP, Global BD
SVP, Manufacturing & Quality
SVP, New Zealand
SVP, Strategic Initatives