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The Food and Drug Administration (FDA) is taking two important steps ensure that new drugs are properly evaluated in women. First, it is formal guidance to drug developers to emphasize its expectations women will be appropriately represented in clinical studies and that new applications will include analyses capable of identifying potential in drug actions or efficacy between the sexes. Second, the agency altering a 16-year-old policy that has excluded most women with"childbearing potential" from the earliest phases of clinical trials. to sex differences is part of a larger effort by the FDA to ensure the safety and efficacy of drugs are adequately studied in the full range patients who will receive therapy and that information is obtained that allow physicians to individualize therapy. These actions are also being in response to questions about whether this country's drug-development produces adequate information about the effects of drugs in women, as as more general issues concerning women's health.
Merkatz et al. (Thu,) studied this question.