children with DIABETES - Ask the Diabetes Team



		Ask the Diabetes Team

Question:
From Vermont, USA:
I understand that a diabetes product is in Phase III Clinical trials. Can you give me any idea about how long these Phase III trials generally take? Also, if the medication were to pass, what's the next step?
Answer:
According to one (probably) reliable source, "Phase III Trial[s take] Approximately 3 years: 1,000-3,000 patients in controlled setting; patients monitored to determine efficacy and monitor for adverse effects."
That's followed by a New Drug Application submitted to the Food and Drug Administration. FDA review takes from 6 months to 2.5 years.
DM
Original posting 14 Mar 1998
Posted to Research: Other

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Last Updated: Sun Jan 15 12:03:00 2006
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