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This latest guidance provides a 15-year update on the recommendations, including the use of CGM devices.
Last week, FDA issued a draft guidance for industry titled “Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products Guidance for Industry.” This draft guidance provides a 15-year update to the FDA’s previous recommendations on efficacy endpoints for such products.
“Diabetes is a common disease that affects nearly 40 million people in the U.S. and is projected to affect more in the coming years. The need for more antidiabetic treatment options is clear,” said Lisa Yanoff, M.D., deputy director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the FDA’s Center for Drug Evaluation and Research. “Today’s draft guidance demonstrates the FDA’s ongoing commitment to providing industry with up-to-date recommendations on how to approach developing new drug therapies.”
The draft guidance outlines the FDA’s general recommendations around evaluating the efficacy of antidiabetic drugs for adults and children with type 1 and/or type 2 diabetes. Topics covered in the draft guidance include:
The FDA will be accepting comments on the guidance until August 24, 2023.
Reference: FDA Roundup: May 26, 2023