| The FDA Office of
Women's Health is creating a powerful new resource that will
ensure sub-population health issues -- including women's health
-- receive the attention they need in the medical review process.
The Demographic Information and Data Repository (DIDR) is a
direct response to a 2002 Congressional mandate calling for
an "agency-wide database focused on women's health activities."
DIDR will house information, data and software to support a
fully electronic review environment that enables highly efficient
processing, archiving and analysis of data -- with an end focus
on product safety and efficacy. FDA will use DIDR to review
clinical studies, enhance product labeling, identify gaps, and
coordinate data collection.
Because OWH has evaluated data gathering and reporting practices
in all Centers of the FDA, we are able to formulate information-gathering
practices that are consistent and flexible enough to work across
the entire agency, so gender and other minority differences
can be captured and reported more efficiently.
Visit OWH's DIDR now.
Read the Report to Congress
[Also available in PDF format (3 MB)]
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