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GUIDANCE DOCUMENT

Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry March 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-N-6084


Docket Number:
FDA-2019-N-6084
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

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).