About the Botanical Review Team
The CDER Botanical Review Team (BRT) resides in the Office of Pharmaceutical Quality (OPQ), and is a part of the Office of New Drug Products (ONDP). The BRT has scientific expertise on a wide range of botanical issues, particularly the complexities associated with raw material control and pharmacognosy of natural products and the inherent challenges associated with natural product drug development. The team also ensures consistent interpretation of the Botanical Drug Development Guidance for Industry.
Please send all inquiries regarding botanicals to CDER-OPQ-Inquiries@fda.hhs.gov
What We Do
- The BRT participates in all phases of review, meetings and decision-making processes as part of a multidisciplinary team for all botanical pre-Investigational New Drug (PIND) applications, Investigational New Drug (IND) applications, Biological License Applications (BLA), Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), 505 B Compounding, and Homeopathic Products, focusing on raw material control and pharmacognosy.
- The BRT follows the review process for INDs and NDAs for botanical drug products described in MaPP 5210.9 Rev 1.
- The BRT responds to external constituents who have general botanical drug development questions and reaches out to the appropriate multidisciplinary experts.
- The BRT works on common botanical issues with:
- The BRT serves as an expert resource for CDER on botanical issues related to raw material control and pharmacognosy of natural products and the inherent challenges associated with natural product drug development.
- The BRT works with external regulatory and scientific groups and presents at and participates in workshops to promote and enhance botanical drug product development.