Better representation
December 19, 2011
THE US Food and Drug
Administration is aiming to address
the historic underrepresentation
of women in clinical studies via a
new draft guidance.
The guidance is intended for
medical device developers and
manufacturers, and outlines
recommendations for designing
and conducting device clinical
studies that may enhance the
enrollment of women, where
appropriate.
“Certain medical products may
elicit different responses in women
than in men,” the FDA said.
“This may be due in part to basic
differences in men and women,
including genetics, hormones,
body size, diet, and sociocultural
issues.
“In addition, certain variables
associated with women, such as
size or certain illnesses, may be
responsible for certain differences
between men and women in the
safety and effectiveness of medical
devices,” the FDA added.
The guidance is now up for a 90
public input period, for details go
to www.fda.gov.
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