Zdrowie i gospodarka · 9.06.2004
Guidance for Industry on Botanical Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Botanical Drug Products." FDA has revised a draft guidance issued on August 11, 2000, in response to comments from industry and other interested persons. The guidance explains the circumstances under which FDA regulations require approval of a new drug application (NDA) 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 sponsors on submitting investigational new drug applications (INDs) for botanical drug products.