FEDERAL DRUG ADMINISTRATION (FDA)


One of Johns Hopkins University First Female Scientists

  • Encourage research and development of botanicals as new drugs

  • CDER Botanical Review Team​

  • 2004 FDA Guidance for Industry: Botanical Drug Products​

  • 2016 FDA Guidance for Industry: Botanical Drug Development

View on Quality Control

To ensure that marketed product batches deliver a therapeutic effect consistent with that observed for product batches tested in clinical studies (i.e., therapeutic consistency), the following will be ensured:

  • Fit -for -purpose clinical design

  • Multiple batches​

  • Dose-response

  • Raw materials control​

  • Cultivar control​

  • Good agricultural/collection practices (GACO)

  • Bioassay