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# New Diabetes Draft Guidance is ‘Step Backward’: Professor
- URL: https://www.fdaweb.com/new-diabetes-draft-guidance-is-step-backward-professor/
- Published: 2020-06-03T12:00:00.000Z
- Updated: 2026-09-14T16:16:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146923

University of Washington professor of medicine and epidemiology **Bruce Psaty** says an FDA draft 2020 guidance on evaluating the safety of new drugs for improving glycemic control “represents a serious step backward.” Writing in a comment [letter](https://www.regulations.gov/document?D=FDA-2019-N-6084-0012&ref=fdaweb.com), Psaty says an earlier 2008 guidance “revolutionized the quantity and quality of information about the risk/benefit profile of drugs approved to treat Type 2 diabetes” and should be continued.

In its [letter](ttps://www.regulations.gov/document?D=FDA-2019-N-6084-0013), AstraZeneca says, “With regard to an overall evaluation of safety for the development of drugs and biologics indicated for improvement of glycemic control in patients with Type 2 diabetes, an excess risk of weight gain or even weight neutrality should be avoided when there are existing therapies which provide weight loss.” The company also makes line-by-line suggested revisions.