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Journal Abstract Search
596 related items for PubMed ID: 17538553
21. Failing the public health--rofecoxib, Merck, and the FDA. Topol EJ. N Engl J Med; 2004 Oct 21; 351(17):1707-9. PubMed ID: 15470193 [No Abstract] [Full Text] [Related]
22. Policy developments in regulatory approval. Temple R. Stat Med; 2002 Oct 15; 21(19):2939-48. PubMed ID: 12325110 [Abstract] [Full Text] [Related]
23. Sure cure: public policy on drug efficacy before 1962. Swann JP. Publ Am Inst Hist Pharm; 1997 Oct 15; 16():223-61. PubMed ID: 11619897 [No Abstract] [Full Text] [Related]
24. The challenges of globalization in pharmaceutical law--is an international drug approval system modeled after the European system worth considering? Purnhagen KP. Food Drug Law J; 2008 Oct 15; 63(3):623-45. PubMed ID: 19031663 [No Abstract] [Full Text] [Related]
25. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Huang SM, Temple R, Throckmorton DC, Lesko LJ. Clin Pharmacol Ther; 2007 Feb 15; 81(2):298-304. PubMed ID: 17259955 [Abstract] [Full Text] [Related]
26. Lessons learned from independent central review. Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J. Eur J Cancer; 2009 Jan 15; 45(2):268-74. PubMed ID: 19101138 [Abstract] [Full Text] [Related]
27. Curbing industry sponsor's incentive to design post-approval trials that are suboptimal for informing prescribers but more likely than optimal designs to yield favorable results. Falit BP. Seton Hall Law Rev; 2007 Jan 15; 37(4):969-1049. PubMed ID: 18363220 [No Abstract] [Full Text] [Related]
28. Losing deference in the FDA's second century: judicial review, politics, and a diminished legacy of expertise. O'Reilly JT. Cornell Law Rev; 2008 Jul 15; 93(5):939-80. PubMed ID: 18618965 [No Abstract] [Full Text] [Related]
29. Deterring inefficient pharmaceutical litigation: an economic rationale for the FDA regulatory compliance defense. Viscusi WK, Rowland SR, Dorfman HL, Walsh CJ. Spec Law Dig Health Care Law; 1996 Mar 15; (205):9-52. PubMed ID: 10156421 [No Abstract] [Full Text] [Related]
30. Biopharmaceutical statistics in a pharmaceutical regulated environment: past, present, and future. Segreti AC, Leung HM, Koch GG, Davis RL, Mohberg NR, Peace KE. J Biopharm Stat; 2001 Nov 15; 11(4):347-72. PubMed ID: 12018784 [Abstract] [Full Text] [Related]
35. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Cross J, Lee H, Westelinck A, Nelson J, Grudzinskas C, Peck C. Pharmacoepidemiol Drug Saf; 2002 Sep 15; 11(6):439-46. PubMed ID: 12426927 [Abstract] [Full Text] [Related]
40. The Food and Drug Administration's use of postmarketing (Phase IV) study requirements: exception to the rule? Steenburg C. Food Drug Law J; 2006 May 15; 61(2):295-383. PubMed ID: 16903034 [No Abstract] [Full Text] [Related] Page: [Previous] [Next] [New Search]