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Patient Advocacy Groups Urge FDA to Update 2008 Cardiovascular Risk in Type 2 Diabetes Guidance

October 24, 2018   |   Alliance for Aging Research Team   |   Patient Advocacy, FDA & Regulatory Policy, Diabetes, Cardiovascular Disease
Stethoscope and insulin syringe lying on diabetes pamphlet.

Today, the below patient advocacy groups, including the Alliance for Aging Research, submitted joint comments to the U.S. Food and Drug Administration (FDA)  in response to the FDA Endocrinologic and Metabolic Drugs Advisory Committee’s request for feedback on its 2008 “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.”

Type 2 diabetes is progressive and multiple therapies are needed over the course of the disease. People with diabetes benefit from a wide range of treatment options and from continued efforts to develop products with more favorable benefit/risk profiles. Given the significant burden of diabetes and prediabetes, it is critical that innovative diabetes interventions continue to be developed. The below groups urge the FDA to review the 2008 guidance to evaluate how to prioritize the continued collection of that information in the broader context of unmet need within diabetes research and development.

Read the comments in the attachment below.

Alliance for Aging Research
Association of Black Cardiologists
Global Coalition on Aging
Men’s Health Network
National Hispanic Medical Association
National Minority Quality Forum
The diaTribe Foundation

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