Regulatory Thinking: My Experience Reviewing Drugs for Obesity and Lipids at FDA
Needs Statement
Physicians, fellows, residents, physician assistants, nurse practitioners, nurses, and other healthcare professionals need to receive regular updates on professional guidelines, advances in basic science and clinical research, and emerging treatment modalities and management strategies for patients with endocrine disorders. The series will explore new models of multidisciplinary care in the field, especially as it relates to patients with cardiometabolic diseases such as obesity and diabetes. The series aims to expand the knowledge of learners, promote adherence to evidence-based guidelines, enhance the quality of endocrinology care, disseminate best clinical practices, and improve patient outcomes.
Target Audience
Physicians, medical students, fellows, residents, nurses, and other health professionals.
Learning Objectives
- Summarize the role of FDA’s Office of New Drugs (OND) to ensure that safe and effective drugs and biologics are available to the American people.
- Introduce some essential and often misunderstood regulatory concepts, including clinical versus surrogate endpoints, substantial evidence of effectiveness, benefit-risk assessment, expedited programs, expanded access, and pediatric drug development.
- Present an approach to reading prescription drug labels (the U.S. prescribing information, USPI).
- Discuss the approval of tirzepatide for weight reduction as an example new drug approval, and recent drug development for obesity and lipid disorders.
Available Credit
- 1.00 AMA PRA Category 1 Credit™
- 1.00 Participation
Price
Thank you for reviewing this Baylor College of Medicine on-demand activity. In order to complete the evaluation and claim credit for your participation, please select the appropriate payment option above. After payment has been completed, you will receive an email confirmation and receipt.
For any questions, contact [email protected].