Trial / Drug Approval Question

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Trial / Drug Approval Question

Postby DenverCO » Wed Aug 03, 2005 4:57 am

When a promising drug is tested and approved outside of the US, how stringent does the FDA's testing/review of the drug have to be before we get approval in this country?

Do we review thier Phase I & II then jump in on our own Phase III? Surely we don't re-invent the wheel.
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