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Dorothy B. Abel, B.S.B.M.E

Dorothy Abel has been a scientific reviewer in the Peripheral Vascular Devices Branch in the Office of Device Evaluation at the Food and Drug Administration (FDA) since 1987, working primarily on vascular grafts and endovascular prostheses. In addition to her work at the FDA, Dorothy is the convener for the vascular prostheses working group for the International Organization of Standardization (ISO). Dorothy frequently presents and publishes regarding the regulation and evaluation of medical devices and is a regular columnist for Endovascular Today.

Affiliation
Food and Drug Administration-Rockville, Maryland

 


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GS02 - Endovascular Medicine 2012-2020: What Does the Future Hold? 
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Date/Time:
January 16, 2012   8:20am - 9:50am
 

 
GS02i - What is the FDA Doing to Accelerate Innovation in the U.S.? 
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Date/Time:
January 16, 2012   9:40am - 9:50am
 
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GS06f - The Current Regulatory Challenges for Advancing EVAR Technology 
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Date/Time:
January 18, 2011   3:30pm - 3:40pm
 
Length:
17 Slides  
 
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31.07 - Debate 17: Regulatory Procedures are Necessary to Protect Patient Safety Even if They Inhibit Innovation Somewhat: The Status Quo in the U.S. is Good 
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Date/Time:
November 21, 2009   10:28am - 10:33am
 
Length:
17 Slides  
 
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  Synched Audio / Slides
 

 
35.03 - Debate 18: Off-Label Use of Devices is Not Acceptable in Most Instances: Reasons Why 
Conference:
 
Date/Time:
November 21, 2009   1:22pm - 1:27pm
 
Length:
14 Slides  
 
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  Synched Audio / Slides
 

 
29.06 - FDA Initiatives to Stop Off-Label Use of Endovascular Cardiovascular Devices and What it Means to Us 
Conference:
 
Date/Time:
November 22, 2008   10:12am - 10:18am
 
Length:
06m 50s - 15 Slides  
 
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  Synched Audio / Slides
 

 
S101 - Alternative Study Designs for Medical Devices: Standardized Objective Performance Criteria (OPCs) and Controlled Data Sets 
Date/Time:
April 28, 2008   3:15pm - 4:15pm
 
Length:
49m 37s - 50 Slides  
 
Total Credits:
1.0 CH  
 
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  Synched Audio / Slides
 

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33.02 - What is the FDA Going to Do About Off-Label Use of Biliary Stents in Blood Vessels? 
Conference:
 
Date/Time:
November 17, 2007   1:00pm - 1:37pm
 
Length:
07m 37s - 21 Slides  
 
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  Synched Audio / Slides
 

 
237 - Ethical Issues Surrounding Live Case Demonstrations [of Novel Technology]: Who Benefits And Who Pays A Price?  
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Date/Time:
November 15, 2006  
 
Length:
07m 00s - 23 Slides  
 
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GS01h - Great Debate I: Does Clinical Investigation Ownership/Payment Influence Outcome? We Have Concerns 
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Date/Time:
January 23, 2006   8:25am - 8:30am
 
Length:
05m 22s - 13 Slides  
 
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GS12s - The Regulation of Thoracic vs. Abdominal Endografts 
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Date/Time:
January 25, 2006   2:30pm - 2:40pm
 
Length:
09m 20s - 26 Slides  
 
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GS06h - What Have We Learned about Pre-clinical Devices? 
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Date/Time:
January 26, 2005   1:00pm - 2:00pm
 
Length:
08m 48s - 25 Slides  
 
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12 Results Found, Showing 1 - 12