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One of Johns Hopkins University First Female Scientists

  • Information on prior human use may substitute for animal toxicology studies. The non-clinical evaluation may be reduced or delayed for certain botanical products entering phase 1 and 2 trials.

  • Flexible CMC approach is emphasized:

  • ​Identification of active components in a botanical mixture may not​ be necessary, but relevant chemical marker(s) are needed for quality control.

  • Further purification generally not needed, but additional control of botanical raw material needed.

  • The overall clinical efficacy and safety requirements are the same for both botanical and non-botanical drugs in order to obtain NDA approval.

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