QUESTIONSDevelopment of Type 2 Diabetes Mellitus Medications: State of the Art Development Issues and Benefit
Venue: Omni Shoreham Hotel
Location: Washington, District of Columbia, United States
| Event Date/Time: Nov 30, 2011 | End Date/Time: Dec 01, 2011 |
| Abstract Submission Date: Oct 28, 2011 |
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CALL FOR ABSTRACTS
All abstracts must be received by October 28, 2011
Member Early-bird Opportunity on or before November 9, 2011
Available on Nondiscount Member Fee only
Join Industry Experts and Regulators to Explore New Solutions and Approaches to Developing Safe and Effective Type 2 Diabetes Mellitus Medications
The development of Type 2 diabetic (T2DM) medications has been significantly impacted by recent data suggesting possible increases in cardiovascular (CV) risk associated with:
• Use of tight glucose control with insulin
• Certain oral drugs used to treat T2DM
• Complexity of properly analyzing benefit and risk
In 2008, the Division of Metabolism and Endocrinology Products of the US Food and Drug Administration (FDA) adopted a new regulatory guidance suggesting that all new T2DM drugs demonstrate CV safety in appropriately designed and powered outcome studies. The EMEA released its draft guidance in 2010. Thus, the approach to the development of medications to treat type 2 diabetes mellitus is undergoing active discussion and the Benefit to Risk analysis is evolving.
All abstracts must be received by October 28, 2011
Member Early-bird Opportunity on or before November 9, 2011
Available on Nondiscount Member Fee only
Join Industry Experts and Regulators to Explore New Solutions and Approaches to Developing Safe and Effective Type 2 Diabetes Mellitus Medications
The development of Type 2 diabetic (T2DM) medications has been significantly impacted by recent data suggesting possible increases in cardiovascular (CV) risk associated with:
• Use of tight glucose control with insulin
• Certain oral drugs used to treat T2DM
• Complexity of properly analyzing benefit and risk
In 2008, the Division of Metabolism and Endocrinology Products of the US Food and Drug Administration (FDA) adopted a new regulatory guidance suggesting that all new T2DM drugs demonstrate CV safety in appropriately designed and powered outcome studies. The EMEA released its draft guidance in 2010. Thus, the approach to the development of medications to treat type 2 diabetes mellitus is undergoing active discussion and the Benefit to Risk analysis is evolving.
