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Guidance for Industry Independent Consultants for Biotechnology Clinical Trial Protocols For questions on the content of this document contact Leonard Wilson, CBER at 301-827-0373 or Susan Johnson, CDER at 301-594-3937. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) August 2004 Guidance for Industry Independent Consultants for Biotechnology Clinical Protocols Additional copies of this guidance are available from: Office of Communication, Training, and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration Suite 200N 1401 Rockville Pike, Rockville, MD 20852-1448 Internet: /cber/guidelines.htm Phone: 800-835-4709 or 301-827-1800 or Office of Training and Communication Division of Communications Management Drug Information Branch, HFD-210 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane, Rockville, MD 20857 Phone: 301-827-4573 Internet: /cder/guidance/index.htm Contains Nonbinding Recommendations