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Question:

From Raleigh, North Carolina, USA:

Why does Cygnus describe their perhaps soon-to-be-FDA-approved GlucoWatch as something available to "adults 18 and over" with diabetes? Why this seemingly arbitrary stipulation?

Answer:

The test data submitted to the FDA for review most likely only included results from people over the age of 18. As a result, the product would be approved only for people over the age of 18. That does not mean that the product cannot be prescribed for others, however, as drugs and similar FDA-reviewed products are sometimes prescribed by physicians to be used in other circumstances ("off-label").

JSH

DTQ-19990818144531
Original posting 31 Aug 1999
Posted to Research: Monitoring

  
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Last Updated: Tuesday April 06, 2010 15:09:06
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