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April 28, 1993

FDA Lifts Ban on Women in Early Drug Tests, Will Require Companies to Look for Gender Differences

JAMA. 1993;269(16):2067. doi:10.1001/jama.1993.03500160029009

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NEW POLICIES at the Food and Drug Administration (FDA) should substantially aid the understanding and advancement of women's health issues.

The date of the official announcement and policy change had not been set at press time. But Eileen Leonard, MD, of the agency's Center for Drug Evaluation and Research, confirms that the rule against including fertile women in early clinical trials, enacted in 1977, is being lifted.

"We are increasingly aware that there are approaches to ensuring the safety of the fetus other than completely excluding women of childbearing potential," says Leonard. Other precautions can be taken, such as informing women of the risks, ensuring that they practice contraception, doing pre-enrollment pregnancy testing, and the like, she says.

'Other Players'  "Also, we recognize that there are other players in clinical trials who should have a say in that decision. Clearly the women, the investigators, and IRBs [institutional review boards] should