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# Guide on Diabetes Drug Safety Evaluations
- URL: https://www.fdaweb.com/guide-on-diabetes-drug-safety-evaluations/
- Published: 2020-03-10T12:00:00.000Z
- Updated: 2026-09-14T16:06:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146284

*Federal Register* notice: FDA has made available a draft guidance entitled “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control.” The document proposes to remove a previous recommendation that sponsors of all new therapies for Type 2 diabetes uniformly rule out risks for ischemic cardiovascular adverse outcomes (cardiovascular outcome trials). It recommends broad pre-approval safety evaluations that examine beyond ischemic (reduced blood flow) cardiovascular disease. The guidance also proposes a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects, to include in clinical trials. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-03-10/pdf/2020-04877.pdf?ref=fdaweb.com).