Implementing the Anticancer Clauses of the Food, Drug, and Cosmetic Act
Kessler, David A.
University of Chicago Law Review 1977 Summer; 44(4): 817-850
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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 ...