FDA panel: Diabetes drug standards need upgrade

July 21, 2008

Panel seeks agency's involvement in requiring diabetes drug manufacturers to conduct long-term studies on their products.

An expert panel advising the U.S. Food and Drug Administration (FDA) is looking to the agency to mandate that diabetes drug manufacturers conductlong-term studies on their products to ensure there are no cardiovascular risks. Most panel members are advising thatcompanies begin studying theirproducts before approved and complete the studies after approval.

The recommendations for standards forapproving diabetes drugs do not include a requirement fornew diabetes drugs to better cardiovascular health, because FDA evidence has shown that no diabetesdrug has been found to improve cardiovascular health.

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