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4. Patients' needs in drug development and regulation. Wardell WM Ann N Y Acad Sci; 1981; 368():187-202. PubMed ID: 7020538 [No Abstract] [Full Text] [Related]
5. The effect of the Drug Regulation Reform Act of 1978 on clinical research, drug availability, and the public health. Temple RJ Ann N Y Acad Sci; 1981; 368():175-85. PubMed ID: 7020537 [No Abstract] [Full Text] [Related]
6. Some observations on the collection of medical event data. Mohberg NR Drug Inf J; 1987; 21(1):55-62. PubMed ID: 10301497 [TBL] [Abstract][Full Text] [Related]
7. Defining the maximum tolerated dose: investigator, academic, industry and regulatory perspectives. Cutler NR; Sramek JJ; Greenblatt DJ; Chaikin P; Ford N; Lesko LJ; Davis B; Williams RL J Clin Pharmacol; 1997 Sep; 37(9):767-83. PubMed ID: 9549630 [No Abstract] [Full Text] [Related]
8. Consider drug efficacy before first-in-human trials. Kimmelman J; Federico C Nature; 2017 Jan; 542(7639):25-27. PubMed ID: 28150789 [No Abstract] [Full Text] [Related]
9. The credibility of the FDA. Blankfield RP Eur J Prev Cardiol; 2013 Dec; 20(6):992-4. PubMed ID: 23867140 [No Abstract] [Full Text] [Related]
10. Drug hepatotoxicity from a regulatory perspective. Senior JR Clin Liver Dis; 2007 Aug; 11(3):507-24, vi. PubMed ID: 17723917 [TBL] [Abstract][Full Text] [Related]
11. The drug regulatory system of the United States Food and Drug Administration: a defense of current requirements for safety and efficacy. Simmons HE Int J Health Serv; 1974; 4(1):95-107. PubMed ID: 4829901 [No Abstract] [Full Text] [Related]
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13. Clinical trials of drugs from the viewpoint of the Food and Drug Administration. Crout JR Clin Pharmacol Ther; 1975 Nov; 18(5 Pt 2):634-6. PubMed ID: 1102238 [No Abstract] [Full Text] [Related]
14. Discovering adverse drug reactions. Lasagna L JAMA; 1983 Apr 22-29; 249(16):2224-5. PubMed ID: 6339764 [No Abstract] [Full Text] [Related]
15. Phase 3 trials and drug labeling. Am J Cardiol; 1974 Oct; 34(4):481-2. PubMed ID: 4415044 [No Abstract] [Full Text] [Related]
17. Federal Right-to-Try Legislation - Threatening the FDA's Public Health Mission. Joffe S; Lynch HF N Engl J Med; 2018 Feb; 378(8):695-697. PubMed ID: 29320302 [No Abstract] [Full Text] [Related]
18. Sounding board. Creative tension: FDA and medicine. Kennedy D N Engl J Med; 1978 Apr; 298(15):846-50. PubMed ID: 345121 [No Abstract] [Full Text] [Related]
19. The United States Food and Drug Administration guidelines on ambulatory blood pressure monitoring. Lipicky R J Hypertens Suppl; 1991 Dec; 9(8):S59. PubMed ID: 1795204 [TBL] [Abstract][Full Text] [Related]