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Research has shown
that women respond differently from men to certain drugs, both
in terms of the drug's effectiveness and its adverse effects.
However, until recently, women of childbearing age did not participate
in clinical trials for new drugs because they could become pregnant
and might harm their unborn children. As a result, not enough
was known about the effects of certain drugs on women.
Today, the FDA is helping manufacturers create better protocols
to remove regulatory barriers and include women in clinical
trials. The Office of Women's Health and the FDA will continue
to evaluate current data to determine future directions through
initiatives such as:
- The development of the Demographic
Information and Data Repository to capture data on subgroup
participation in clinical trials and data resulting from subgroup
analysis
- The OWH Science Program, which
continues to fund projects that fill gaps in the knowledge
base related to gender-related issues
- Pregnancy initiatives that aim to:
- revise the pregnancy subsection of a drug label so
it adequately imparts all information necessary to prescribe
for and counsel a pregnant or lactating patient, and
- improve the quality and quantity of data available
for the label
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