Women in Clinical Trials: An Introduction
Merkatz, Ruth B.
Food and Drug Law Journal. 1993; 48(2): 161-166.
Aged; Autonomy; Clinical Trials; Consent; Drugs; Federal Government; Females; Fetuses; Food; Government; Government Regulation; Health; Human Experimentation; Information Dissemination; Informed Consent; Investigational Drugs; Males; Medicine; Placebos; Public Policy; Regulation; Research; Research Design; Research Subjects; Rights; Selection of Subjects; Toxicity; 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 ...