美国FDA临床试验问答.pdfVIP

Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2002 Procedural Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm or 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 /cber/guidelines.htm. Fax: 1-888-CBERFAX or 301-827-3844 (Tel) Voice Information System at 800-835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration