FDA Issues Final Guidance for Industry Regarding Botanical Drug Products

摘要

In June, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) issued its final guidance for members of the herb and pharmaceutical industries for the development of drug products from botanicals. The Guidance forIndustry: Botanical Drug Products finalizes draft guidance issued in August 2000 which was described in HerbalGram 50. To clarify, the final guidance pertains to the process of developing a drug product from a chemically complex botanical and does not apply to the development of highly purified, single chemical compounds derived from botanical sources, like numerous conventional drugs that are made from plants. For example, atropine is made from deadly nightshade (Atropa belladonna L., Solanaceae) and other plant sources (such as Duboisia spp., Solanaceae), colchicine from autumn crocus (Colchicum autumnale L., Liliaceae), digoxin from foxglove (Digitalis purpurea L., Scrophulariaceae), lanoxin from woolly foxglove (D. lanata Ehrh., ScrophulariaceaeA and many others. Nor does this guidance deal with the development of dietary supplements from botanicals under the Dietary Supplement Health and Education Act of 1994 (DSHEA).