Historical Background of Changes in FDA Policy on the Study and Evaluation of Drugs in Women
Merkatz, Ruth B.
Junod, Suzanne White
ACADEMIC MEDICINE 1994 September; 69(9): 703-707
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Merkatz, Ruth B.; Temple, Robert; Sobel, Solomon; Feiden, Karyn (Working Group on Women in Clinical Trials, 1993-07-22)
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 ...