Marks, H. M. 1997b. Managing chance: Statistics and therapeutic experiments, 1950-1960. The progress of experiment: Science and therapeutic reform in the United States, 1900-1990. Cambridge, NY: Cambridge University Press. Pp. 71-97.

NIH (National Institutes of Health). 2011. Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE). (accessed April 25, 2011).

Nissen, S. E., and K. Wolski. 2007. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. New England Journal of Medicine 356(24):2457-2471.

Office of Surveillance and Epidemiology. 2007. An overview of RiskMAPs. Washington, DC: US Food and Drug Administration.

Platt, R., M. Wilson, K. A. Chan, J. S. Benner, J. Marchibroda, and M. McClellan. 2009. The new Sentinel network—improving the evidence of medical-product safety. New England Journal of Medicine 361(7):645-647.

Platt, R., R. M. Carnahan, J. S. Brown, E. Chrischilles, L. H. Curtis, S. Hennessy, J. C. Nelson, J. A. Racoosin, M. Robb, S. Schneeweiss, S. Toh, and M. G. Weiner. 2012. The U.S. Food and Drug Administration’s Mini-Sentinel program: Status and direction. Pharmacoepidemiology and Drug Safety 21(Suppl 1):1-8.

Robb, M. A., J. A. Racoosin, R. E. Sherman, T. P. Gross, R. Ball, M. E. Reichman, K. Midthun, and J. Woodcock. 2012. The U.S. Food and Drug Administration’s Sentinel initiative: Expanding the horizons of medical product safety. Pharmacoepidemiology and Drug Safety 21(Suppl 1):9-11. Rosen, C. J. 2007. The rosiglitazone story—lessons from an FDA advisory committee meeting. New England Journal of Medincine 357(9):844-846.

Shane, R. 2009. Risk Evaluation and Mitigation Strategies: Impact on patients, health care providers, and health systems. American Journal of Health-System Pharmacy 66(24 Suppl. 7):S6-S12.

Stang, P. E., P. B. Ryan, J. A. Racoosin, J. M. Overhage, A. G. Hartzema, C. Reich, E. Welebob, T. Scarnecchia, and J. Woodcock. 2010. Advancing the science for active surveillance: Rationale and design for the Observational Medical Outcomes Partnership. Annals of Internal Medicine 153(9):600-606.

Strom, B. L. 2006. How the U.S. drug safety system should be changed. JAMA 295(17):2072-2075. Wood, A. J. 2006. A proposal for radical changes in the drug-approval process. New England Journal of Medicine 355(6):618-623.

Wood, A. J. J., C. M. Stein, and R. Woosley. 1998. Making medicines safer—the need for an independent drug safety board. New England Journal of Medicine 339(25):1851-1854.

Woodcock, J., R. E. Behrman, and G. J. Dal Pan. 2011. Role of postmarketing surveillance in contemporary medicine. Annual Review of Medicine 62(Feb):1-10.

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement