Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control." This draft guidance replaces the guidance for industry entitled "Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" and the draft guidance for industry "Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention," both of which are being withdrawn. This draft guidance outlines the Agency's current recommendations on the evaluation of safety for new drugs and biologics to improve glycemic control in patients with type 2 diabetes. Publication of this guidance is intended to provide clarity on the expectations for the development of drugs and biologics to improve glycemic control and to serve as a focus for commentary and feedback.