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 Sep; 69(9): 703-707.
Drugs; Discrimination; Evaluation; Federal Government; Females; Fetuses; Food; Government; Guidelines; Health; Historical Aspects; Human Experimentation; Males; Prisoners; Public Policy; Regulation; Research; Research Design; Research Subjects; Selection of Subjects; Social Discrimination; Women's Health;
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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 ...
Merkatz, Ruth B.; Temple, Robert; Sobel, Solomon; Feiden, Karyn (Working Group on Women in Clinical Trials, 1993-07-22)