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Question:

From Virginia, USA:

Is there any way to affect the process by which the FDA approves devices through the pre-market approval process? My wife and I are exhausted checking my type 1 diabetic teenage daughter's sugars every two hours every night. The Freestyle Navigator would help immensely. The FDA says the status is confidential. Therasense is prohibited from discussing it. I know the HIV community has had some impact on speeding medications through the process.

Answer:

Since the FDA is a part of our government, if you are unhappy with their actions or decisions, you should contact your elected representatives to make your feelings known.

In the specific case of continuous glucose sensors, CWD was able to muster a presence at the FDA panel meetings for the MiniMed CGMS and Cygnus GlucoWatch. In the case of the GlucoWatch, a letter from CWD founder Jeff Hitchcock was read into the record by Sonia Cooper (now president of the CWD Foundation). We will continue to support the approval of continuous glucose sensors to help children with diabetes and their families to lead better lives until diabetes is cured.

JSH

DTQ-20050113153829
Original posting 21 Jan 2005
Posted to Other

  
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Last Updated: Tuesday April 06, 2010 15:10:00
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