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9. U.S. Food and Drug Administration inspections of clinical investigators: overview of results from 1977 to 2009. Morgan-Linnell SK; Stewart DJ; Kurzrock R Clin Cancer Res; 2014 Jul; 20(13):3364-70. PubMed ID: 24737548 [TBL] [Abstract][Full Text] [Related]
10. FDA overview and current challenges in regulation of human subject protection. Food and Drug Administration. Nightingale SL J Int Assoc Physicians AIDS Care; 1997 Jan; 3(1):24-6. PubMed ID: 11363959 [TBL] [Abstract][Full Text] [Related]
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13. Medical devices; procedures for investigational device exemptions--Food and Drug Administration. Final rule. Fed Regist; 1980 Jan; 45(13):3732-59. PubMed ID: 10248822 [TBL] [Abstract][Full Text] [Related]
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18. FDA's new drug evaluation process: a general overview. Walters PG J Public Health Dent; 1992; 52(6):333-7. PubMed ID: 1432918 [TBL] [Abstract][Full Text] [Related]
19. The IRB as deputy sheriff: proposed FDA regulation of the institutional review board. Huff TA Clin Res; 1979 Apr; 27(2):103-8. PubMed ID: 10241072 [No Abstract] [Full Text] [Related]
20. Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world. Caldron PH; Gavrilova SI; Kropf S Drug Des Devel Ther; 2012; 6():53-60. PubMed ID: 22563236 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]