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8. The concept of the IRB and bureaucratic reality: an exchange of letters. van Eys J; Levine RJ IRB; 1984; 6(4):8-10. PubMed ID: 11649563 [No Abstract] [Full Text] [Related]
9. No moratorium on clinical trials. Vogel G Science; 1998 Jan; 279(5351):648. PubMed ID: 9471725 [No Abstract] [Full Text] [Related]
10. Proposal for a coordinated framework for regulation of biotechnology. U.S. Office of Science and Technology Policy Fed Regist; 1984 Dec; 49(252):50856-907. PubMed ID: 11655658 [No Abstract] [Full Text] [Related]
11. FDA cracks down on labeling, initiates trial result reporting. Osborne R; Waltz E Nat Biotechnol; 2008 Nov; 26(11):1203-4. PubMed ID: 18997742 [No Abstract] [Full Text] [Related]
12. Proceedings of the National Conference on Clinical Trials Methodology. Clin Pharmacol Ther; 1979 May; 25(5 Pt 2):629-766. PubMed ID: 35299 [No Abstract] [Full Text] [Related]
13. The Food and Drug Administration's role in the protection of human subjects. Nightingale SL IRB; 1983; 5(1):6-9. PubMed ID: 11649511 [No Abstract] [Full Text] [Related]
14. Coordinated framework for regulation of biotechnology; establishment of the Biotechnology Science Coordinating Committee; notice. U.S. Office of Science and Technology Policy Fed Regist; 1985 Nov; 50(220):47174-95. PubMed ID: 11655733 [No Abstract] [Full Text] [Related]
15. Coordinated framework for regulation of biotechnology; announcement of policy; notice for public comment. U.S. Office of Science and Technology Policy Fed Regist; 1986 Jun; 51(123):23302-50. PubMed ID: 11655807 [No Abstract] [Full Text] [Related]
16. Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop. De Gruttola VG; Clax P; DeMets DL; Downing GJ; Ellenberg SS; Friedman L; Gail MH; Prentice R; Wittes J; Zeger SL Control Clin Trials; 2001 Oct; 22(5):485-502. PubMed ID: 11578783 [TBL] [Abstract][Full Text] [Related]