The Food and Drug Administration has announced the availability of a draft guidance document entitled “Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling”. The guidance adds new sections to discuss its applicability to audiovisual, broadcast, and computer-based advertisements, and promotional labelling; a new section to discuss the placement, size and prominence of the proprietary (brand) name and established (generic, INN) name for products with two or more active ingredients; and it documents the applicability of this guidance to animal prescription drugs and biological products.

Copies of the draft guidance are available from the Drug Information Branch, (HFD- 210), Center for Drug Evaluation & Research (CDER), 5600 Fishers Lane, Rockville MD 20857, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.

Reference: Federal Register 64(48): 12341-2 (1999).