Shaw T. Chen, M.D. Ph.D.
Associate Director for Special Product Review
Botanical Drug Products
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 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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