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Symposium Summary
Food and Drug Administration (FDA)/National Institutes of
Health (NIH) Joint Symposium on Diabetes: Targeting Safe and
Effective Prevention and Treatment. The purpose of the symposium
is to define the current state of the prevention and management
of diabetes and to identify and discuss therapeutic gaps and
hurdles to safe and effective prevention and treatment of
type 1 and type 2 diabetes mellitus. The symposium is intended
to provide assistance to FDA, clinical and basic scientists,
and the interested pharmaceutical industry in their efforts
to reduce the burden of diabetes and improve the health of
all people with diabetes.
The symposium will provide a forum for
discussion of diabetes-related topics, including the following:
• Important disease outcomes
that are or should be targeted in the development of drugs,
devices, and cell-based therapies for type 1 and/or type 2
diabetes.
• Issues surrounding the
use of surrogate or intermediate measures of clinical effect
in assessments of novel therapeutic approaches to prevention
and treatment.
• Clinical, scientific,
and regulatory issues surrounding development of new medical
technologies for the treatment of metabolic syndrome and for
the prevention of type 2 diabetes.
The symposium will include morning and afternoon sessions
during which a discussion of diabetes and related issues associated
with diabetes prevention and treatment will be presented.
FDA and NIH are asking experts to provide presentations on
specific issues, with discussion time following presentations
between speakers and attendees.
Federal Registry Notice regarding this
meeting can be found HERE.
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