August 31, 1999
Research: Monitoring
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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:
From: DTeam Staff
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
