Draft Guidance for Industry on Botanical Drug Products; Availability; Reopening of Comment Period

Samenvatting

The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance for industry entitled "Botanical Drug Products" until March 15, 2001. This draft guidance explains the circumstances under which FDA approval of a new drug application (NDA) is required for marketing of a botanical drug product and when such a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. FDA is taking this action in response to a request for an extension.