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About FDA
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Botanical Review Team (BRT)
Frequently Asked Questions on Botanical Drug Development
Shaw T. Chen, M.D. Ph.D.
Associate Director for Special Product Review
Botanical Drug Products
About the Botanical Review Team
The CDER Botanical Review Team (BRT) provides scientific expertise on botanical issues to the reviewing staff and ensures consistent interpretation of the Guidance for Industry-Botanical Drug Products.
What We Do
- The BRT participates in all phases of review, meetings and decision-making processes for all botanical pre-Investigational New Drug (IND) applications, INDs, and New Drug Applications (NDAs).
- The BRT follows the review process for INDs and NDAs for botanical drug products described in MaPP 6007.1 Review of Botanical Drug Products.
- The BRT responds to external constituents who have general botanical drug development questions.
- The BRT responds to issues and meeting requests from FDA's Office of the Commissioner and works on common botanical issues with
- the National Center for Complementary and Alternative Medicine
- the Office of Dietary Supplements at the National Institutes of Health
- FDA's Center for Food Safety and Applied Nutrition (CFSAN)
- The BRT serves as an expert resource for CDER on all botanical issues, and
- The BRT works with external regulatory and scientific groups, and presents at and participates in workshops to promote and enhance botanical drug product development and knowledge.
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