Regulatory and Safety: Obesity Drugs

Diabetes & Obesity Series

Safety and Regulatory Aspects of Obesity Drugs

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Dr. David Orloff
Executive Director of Regulatory Affairs
Medpace

Dr. Orloff discusses the current and potential future regulatory issues for obesity and diabetes drugs, how FDA and industry is moving toward levels of safety for these drug classes.

Others in the Series

• Getting Smart about Diabetes

• Type 2 Diabetes

• Challenges Sponsors Face in Diabetes Trials

• Role of Biomarkers

• Challenges to the Site

• Subject Recruitment and Retention

• Finding the Patients

• Understanding for Better Retention

• Role of Imaging in Diabetes Trials

• Obesity Drugs and Co-Morbidities

• Safety and Regulatory Aspects of Obesity Drugs

• Pediatric Clinical Trials

Diabetes Resources

• Articles, Multimedia
• Diabetes Drugs in Development, 2009

• Diabetes: The Forgotten Disease

• ePRO Use in Obesity and Hypertension Trials

• Recorded Webcasts from the European Association for the Study of Diabetes Annual Meeting, October 2009

• FDA Scientists Recognized at Diabetes Technology Meeting

Associations and Societies

• American Association of Diabetes Educators

• American Diabetes Association, Professional Section

• The Endocrine Society

• European Association for the Study of Diabetes

• The Diabetes Technology Society

Clinical Trials

• Clinical Trials for Type II Diabetes in Adults

• Clinical Trials for Type II Diabetes in Children

Obesity Resources

Articles, Multimedia

• Clinical Trial Challenges in Obesity

• Diabesity

• The Obesity Pipeline

• Key Drug Execs Talk Obesity

• Primary Care/Health Care Issues

• Recent Study Pinpoints Weight Gain in Children Using Antipsychotics

Associations and Societies

• The Obesity Society

• International Association for the Study of Obesity

• European Association for the Study of Obesity

Clinical Trials

• Clinical Trials for Obese Children

• Clinical Trials for Obese Adults

• Clinical Trials for Metabolic Syndrome in Adults