The Endocrinologic and Metabolic Drugs Advisory Committee forthe Food and Drug Administration (FDA), of which I am a member,convened in early July to consider whether data on long-termcardiovascular safety should be required for new and existingtherapies for type 2 diabetes mellitus, whether trials shouldmerely rule out harm or must show cardiovascular benefit, andat what point in the drug-approval process and by what methodscardiovascular data should be obtained.
Clinical treatment goals for patients with type 2 diabetes includealleviating acute symptoms of hyperglycemia and forestallingdiabetes-related complications. Drugs that are approved by theFDA . . . [Full Text of this Article]
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Dr. Goldfine is head of the Section on Clinical Research at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School — both in Boston.
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