United States of America. The Food and Drug Administration has announced the availability of a draft guidance document entitled “Guidance for Industry: for the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the FDA Form 356h, Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.”

Copies of the draft guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), 1401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(s): Federal Register 63(132): 37401-2 (1998).