Botanical Drug

Botanical drug” is a form of finished product containing ingredients and or constituents of vegetable matter. The classification includes whole plants or plant parts and also include algae or macroscopic fungi. A botanical must undergo identification and taxonomic classification. The most important step of the process and, for botanicals, the most difficult step to satisfy is FDA’s review and acceptance of the chemistry, manufacturing, and controls (CMC). Drug if it is intended for use in the diagnosis, cure, mitigation, or treatment of disease in humans. Botanical drug products often have unique features.

  • Botanical Drug Development under INDS
  • Botanical Drug Substances
  • Clinical Studies of Botanical Drugs for Serious Conditions
  • Botanical New Drug Applications

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