Issue Date: March 10, 2020
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry
The purpose of this guidance is to provide the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall evaluation of safety for the development of drugs and biologics indicated for improvement of glycemic control in patients with type 2 diabetes mellitus. The recommendations in this guidance reflect discussions at the Endocrinologic and Metabolic Drugs Advisory Committee meeting held October 24–25, 2018, that considered FDA’s review of cardiovascular (CV) outcome trials (CVOTs).
Download the Guidance Document
