Inclusion of Women in Clinical Trials: A Historical Overview of Scientific, Ethical, and Legal Issues
Merkatz, Ruth B.
JOGNN: Journal of Obstetric, Gynecologic, and Neonatal Nursing 1998 January/February; 27(1): 78-84
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Inclusion of Women in Clinical Trials: A Historical Overview of Scientific, Ethical, and Legal Issues Merkatz, Ruth B. (1998)During the past 20 years, there has been a dramatic shift in scientific, ethical, and legal perspectives regarding the inclusion of women in clinical trials conducted in the United States. A historical overview of why women ...
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 ...