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The FDA has taken a big step in encouraging drug companies to include pregnant women in clinical trials, issuing a draft guidance outlining how to do so safely and ethically.

Nearly 4 million women in the U.S. give birth each year, but few drugs have been approved as safe and effective to use during pregnancy. The new guidance aims to help drug companies address those information gaps “through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk.”


Experts say it’s a sign of progress on an issue that’s long plagued pregnant women and their physicians.

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