[Skip navigation] FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
Office of Drug Evaluation I

Botanical Review Team (BRT)

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 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.

Back to Top     Offices and Divisions

Created: 3/26/2004
Updated: 6/9/2004
horizonal rule