The “art” of medicine and the “smokescreen” of the randomized trial off-label use of vascular devices-Reference-Cited by-同舟云学术

The “art” of medicine and the “smokescreen” of the randomized trial off-label use of vascular devices

Published:2008-12-01 Issue:7 Volume:72 Page:998-1002
ISSN:1522-1946
Container-title:Catheterization and Cardiovascular Interventions
language:en
Short-container-title:Cathet. Cardiovasc. Intervent.

Author:

Ansel Gary M.,Jaff Michael R.

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging,General Medicine

Reference14 articles.

1. IRB Information Sheets: Off-Label and Investigational Use of Marketed Drugs, Biologics and Medical Devices. Use of a marketed product in this Drug Application (IND), Investigational Device Exemption (IDE). Available at: www.fda.gov/oc/ohrt/irbs/offlabel.html (accessed on July 31, 2008).

2. David Y,Hyman WA. Issues associated with off label use of medical devices. In Proceedings of Annual International Conference of IEEE Engineering in Medicine and Biology Society, 2007; 3556-3558.

3. United States Food and Drug administration information sheets. http://www.fda.gov/OC/OHRT/IRBS/offlabel.html accessed 09/09/2008.

4. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350 ( 2001).

5. FDA, off-label drug use, and informed consent: Debunking myths and misconceptions;Beck;Food Drug Law J,1998

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