FDA releases draft guidance on diabetes care and prevention

WASHINGTON The Food and Drug Administration is making a new draft guidance available for the pharmaceutical industry called, “Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention.”

Draft guidances provide recommendations for developing drugs and therapeutic biologics. Because the FDA recognizes the scope of the diabetes mellitus problem, the agency has recognized the need for new products that can be used as part of a comprehensive treatment strategy in the treatment and prevention of diabetes.

According to the FDA, the draft guidance provides recommendations on the following topics related to the treatment of type 1 and type 2 diabetes mellitus:

• Diabetes-specific preclinical studies;
• Different study designs in different phases of drug development for both type 1 and type 2 diabetes
• Study population considerations in different phases of development;
• Specific statistical issues related to development of drugs and biologics intended for the treatment of diabetes.

In addition to the draft guidance, FDA plans to convene a public advisory committee meeting to discuss new approaches for the development of products for the treatment of diabetes.