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2Food and Drug Administration.Code of federal regulations(Title 21,Volume 5) (CITE:21 CFR312.60-312.70),Chapter Ⅰ,SubChapter D-drug for human use[EB/OL].http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm,2009-04-01.
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4Food and Drug Administration.Compliance program manual[EB/OL].http://www.fda.gov/ICECI/ComplianceManuals/ Compliance Program Manual/default.htm # drugs,2010-05-08.
5Food and Drug Administration.The food and drug administration amendments act of 2007(FDAAA or US Public Law 110-85)[EB/OL].http://www.fda.gov/Regulatorylnformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007 / default.htm,2007-09-27.
同被引文献11
1U.S. Food and Drug Administration. 21CFR: CFR-Code of feder- al regulations title 21 [ EB/OL]. [2011 -05 - 18 ]. http://www. accessdata, fda. gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch, cfm.
2European Medicines Agency. ICH-E6: ICH topic E6(R1) guide- line for good clinical practice [ EB/OL ]. [ 2011 - 05 - 18 ]. ht- tp ://www. ema. europa, eu/docs/en_GB/document_library/Sci- entific_guideline/2009/O9/WCSO0002874, pdf.
3LEVINSON DR. The Food and drug administration's oversight of clinical trials[ EB/OL]. (2010 - 05 - 18 ). http ://oig. hhs. gov/ oei/reports/oei-01-06-00160, pdf.
