
Encourage research and development of botanicals as new drugs
CDER Botanical Review Team
2004 FDA Guidance for Industry: Botanical Drug Products
2016 FDA Guidance for Industry: Botanical Drug Development
View on Quality Control
To ensure that marketed product batches deliver a therapeutic effect consistent with that observed for product batches tested in clinical studies (i.e., therapeutic consistency), the following will be ensured:
Fit -for -purpose clinical design
Multiple batches
Dose-response
Raw materials control
Cultivar control
Good agricultural/collection practices (GACO)
Bioassay