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U.S. Department of Health and Human Services

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This Week In FDA History - July 22, 1993

Photo of woman selected for drug study
July 22, 1993:
Revising a 1977 policy that excluded women of childbearing potential from early drug studies, FDA issues guidelines calling for improved assessments of possible gender differences in responses to new medications. Companies are encouraged to include patients of both sexes in their investigations of drugs and to analyze any gender-specific phenomena.
FDA in 2006

In the year 2000, the FDA went a step further with a new regulation giving the agency the authority to halt studies of new drugs to treat life-threatening diseases if clinical trials excluded women solely because they could become pregnant. As a complement to these regulatory initiatives, the FDA's Office of Women's Health funds research studies that help fill the gap between basic research and regulatory decision-making. To date, the Office of Women's Health
has provided approximately $12 million for over 100 women's health research studies on topics ranging from cancer, HIV, and osteoporosis to dietary supplements, dioxins and statistical approaches to gender analysis. The results of these studies appear in scientific journals, provide information for the development of regulations and guidance, and contribute to the agency's educational and outreach programs.