التفاصيل البيبلوغرافية
| العنوان: |
The Regulatory Perspectives on Endoscopic Devices for Obesity |
| المؤلفون: |
Marrone, April K., Antonino, Mark J., Silverstein, Joshua S., Betz, Martha W., Venkataraman-Rao, Priya, Golding, Martin, Cordray, Diane, Cooper, Jeffrey W. |
| المصدر: |
Gastrointestinal Endoscopy Clinics of North America; April 2017, Vol. 27 Issue: 2 p327-341, 15p |
| مستخلص: |
The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study. |
| قاعدة البيانات: |
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