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U.S. Department of Health and Human Services

Drugs

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Botanical Drug Review

The CDER Botanical Review Team (BRT) provides scientific expertise on botanical issues to CDER reviewing staff and ensures consistent interpretation of the Guidance for Industry: Botanical Drug Products (PDF - 437KB). 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). 

More information on BRT

 

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