(1998; 18 pages)
Human plasma-derived biological products or animal plasma or serum-derived products - draft guidance available
United States of America. The Food and Drug Administration has announced the availability of a guidance for industry entitled "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-derived Biological Products or Animal Plasma or Serum-derived Products", which is intended to assist applicants in the preparation of the content and format of these sections of a biologicals licence application for human plasma-derived products, animal plasma or serum-derived products.
Copies of the guidance may be obtained from the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 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(13): 3145-6 (1998).