ABSTRACT
Botanical or herbal products have been used extensively as drug treatments in the complementary and alternative medical (CAM) system in many regions of the world, but have not been subjected to the same rigorous evaluation by regulatory agencies as that for modern nonbotanical pharmaceutical agents. To facilitate further development of new drugs from botanical sources, the Center for Drug Evaluation and Research (CDER) of U.S. Food and Drug Administration (FDA) has published a draft Guidance for Industry: Botanical Drug Product in August, 2000. The Guidance has since been published in its final form in June of 2004 (see link to the document given in Ref. 1). The new regulatory approaches in the Guidance take into consideration the unique features of the botanical drugs and the substantial past human experiences. Its major provisions will be summarized below.
