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U.S. Department of Health and Human Services

About FDA

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Botanical Review Team (BRT)

About BRT

Organization

What is a Botanical Drug?

Frequently Asked Questions on Botanical Drug Development

Guidance for Industry

Related Botanical Links

Contact Us

 

Sau (Larry) Lee, Ph.D.
Acting Associate Director for Research Policy and Implementation
Immediate Office, Office of Pharmaceutical Science

Leader, Botanical Review Team

 

 

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 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.