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Previous Volume 329:292-296 July 22, 1993 Number 4

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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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 women will be appropriately represented in clinical studies and that new drug applications will include analyses capable of identifying potential differences in drug actions or efficacy between the sexes. Second, the agency is altering a 16-year-old policy that has excluded most women with "childbearing potential" from the earliest phases of clinical trials.

Attention to sex differences is part of a larger effort by the FDA . . . [Full Text of this Article]

Sex-Specific Issues in Drug Response

Identifying Sex-Related Effects in Clinical Trials

Guidelines for the Evaluation of Sex Differences in the Clinical Evaluation of Drugs

The Inclusion of Women in Early Phases of Clinical Trials

Testing Drugs in Pregnant Women

Source Information

Address reprint requests to Dr. Ruth B. Merkatz at the Food and Drug Administration, HS-1, 5600 Fishers La., Rockville, MD 20857.

References

Appendix

Related Letters:

FDA Policy on Women in Drug Trials
Chavkin W., Kessler D. A., Merkatz R. B., Temple R.
Extract | Full Text  
N Engl J Med 1993; 329:1815-1816, Dec 9, 1993. Correspondence

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