This guidance provides recommendations for the development of drugs and therapeutic biologics regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the treatment and prevention of diabetes mellitus. The intention of this guidance is to serve as a focus for continued discussions among the review divisions, pharmaceutical sponsors, academic community, and the public. The organization of the guidance parallels the development plan for a particular drug or biologic. In the following discussion, we briefly describe type 1 and type 2 diabetes mellitus and treatment goals, discuss issues relevant to preclinical development, and then provide guidance on issues related to trial design, endpoints appropriate for different phases of development, and eligible populations. These issues are addressed for both type 1 and type 2 diabetes mellitus.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.