Zdrowie i gospodarka · 11.08.2000

Draft Guidance for Industry on Botanical Drug Products; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Botanical Drug Products." This draft guidance explains the circumstances under which FDA approval of a new drug application (NDA) is required for marketing of a botanical drug product and when such a product may be marketed under an over-the-counter (OTC) drug monograph. It also provides guidance to researchers and manufacturers on conducting initial and expanded clinical investigations of botanical drug products. After evaluating the comments it receives, FDA will issue this guidance in final form to encourage the submission of investigational new drug applications (IND's) for botanical drugs.