Women in Clinical Trials of New Drugs: A Change in Food and Drug Administration Policy
Creator
Merkatz, Ruth B.
Temple, Robert
Sobel, Solomon
Feiden, Karyn
Bibliographic Citation
New England Journal of Medicine 1993 July 22; 329(4): 292- 296
Date
1993-07-22Subject
Publisher
Working Group on Women in Clinical Trials
Collections
Metadata
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Women in Clinical Trials of New Drugs: A Change in Food and Drug Administration Policy
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 ...