Women in Clinical Trials of New Drugs: A Change in Food and Drug Administration Policy
Merkatz, Ruth B.
New England Journal of Medicine 1993 July 22; 329(4): 292- 296
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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 ...