United States of America. The Food and Drug Administration has announced the availability of a draft guidance document entitled “Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergen Extract or Allergen Patch Test”, which provides guidance for marketing applications.

Copies of the draft guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401 Rockville Pike, Rockville MD 20852-1448, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cber/guidelines.htm.

Reference: Federal Register 63(166): 45826-7 (1998).