Q8, Q9, and Q10 Questions and Answers英文学习资料.pdfVIP

Guidance for Industry Q8, Q9, and Q10 Questions and Answers 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 2010 ICH Guidance for Industry Q8, Q9, and Q10 Questions and Answers Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 800-835-4709 or 301-827-1800 /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm