Botanical Drug Development Pathway

Modern herbal medicines in the form of pills or capsules with demonstrated safety and efficacy on large-scale populations are good candidates for US prescription botanical drug development:

• Choosing known safe and effective herbal medicines reduces the time and cost of drug discovery
• Demonstrated safety significantly increases success rates from pre-clinical tests up to phase-IIa
• Demonstrated efficacy significantly improves success rates of phase-IIb and Phase-III trials

The technical challenge of developing CMC contents in FDA IND filing is tedious but doable. The US FDA encourages sponsors to develop hemp products through the botanical drug development pathway to bear medical claims.