The Food and Drug Administration's Oversight of Clinical Trials
Levinson, Daniel R.
Washington, DC: Department of Health and Human Services. Office of Inspector General; 2007 September 28: 34 p. [online]. Accessed: http://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf [2007 September 28]
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Merkatz, Ruth B.; Temple, Robert; Sobel, Solomon; Feiden, Karyn; Kessler, David A. (Working Group on Women in Clinical Trials, 1993-07-22)The Food and Drug Administration (FDA) is taking two important steps to ensure that new drugs are properly evaluated in women. First, it is providing formal guidance to drug developers to emphasize its expectations that ...
Symptom Reduction and Suicide Risk Among Patients Treated With Placebo in Antipsychotic Clinical Trials: An Analysis of the Food and Drug Administration Database Khan, Arif; Khan, Shirin R.; Leventhal, Robyn M.; Brown, Walter A. (2001-09)