Views
The Center for Drug Evaluation and Research (CDER) generally considers the entire mixture as the active pharmaceutical ingredient (API) for botanical drugs. Regulations on fixed combination drugs do not apply to the botanical products.
A conventional CMC approach for small-molecule drugs (mainly based on chemical testing) is generally insufficient for quality control of botanical products.
Information on prior human use may provide some indication of the safety profile of botanical products.
Botanical Review Team
Established in 2003, resides in the Office of Pharmaceutical Quality since 2013
Provides scientific expertise on botanical issues to the review staff
Ensures consistent interpretation and implementation of the Botanical Guidance and related policies
Consolidates experiences in the regulatory review of botanical applications and compiles information on the status of botanical drug submissions for agency management