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FDA insists on more women in drug trials

BMJ 1997; 315 doi: https://doi.org/10.1136/bmj.315.7112.831f (Published 04 October 1997) Cite this as: BMJ 1997;315:831
  1. Deborah Josefson
  1. San Francisco

    The Food and Drug Administration in the United States has proposed new regulations to force drug companies to include women in all phases of clinical trials.

    Although women constitute roughly half of the population, traditionally both drug companies and the government have excluded many women from participating in trials of new drugs because of fears that they may induce teratogenic damage to a developing fetus. Additionally, drug companies have been worried that a woman's hormonal cycles could interfere with the metabolism and efficacy of some treatments. …

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