Approval of New Drugs in the United States. Comparison With the United Kingdom, Germany, and Japan
Creator
Kessler, David A.
Hass, Arthur E.
Feiden, Karyn L.
Lumpkin, Murray
Temple, Robert
Bibliographic Citation
JAMA: The Journal of the American Medical Association 1996 December 11; 276(22): 1826-1831
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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 ...