guidance for industry - food and drug.pdf

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guidance for industry - food and drug.pdf

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guidance for industry - food and drug

Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients 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) May 2005 Pharmacology/Toxicology J: \!GUIDANC\5544fnlcln2.doc 4/15/2005 Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients Add itional copies are available from: Off ice of Training and Communications Division of Drug Inf ormation, 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 Off ice 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 (Tel) 800-835-4 709 or 301-827-1800 /cber/guidelines.htm U.S. Department of Health and Human Services Food and Drug Administration Center for