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Q: FDA anda approval process for new topical formula ( No Answer,   0 Comments )
Subject: FDA anda approval process for new topical formula
Category: Health > Medicine
Asked by: billfromnw-ga
List Price: $20.00
Posted: 10 Nov 2006 13:41 PST
Expires: 26 Nov 2006 02:51 PST
Question ID: 781721
My question is about the FDA regulatory process for new drugs.
Specifically, the abbreviated process for a new formulation of a
generic drug currently approved.

My company is planning to license a formula for a topical treatment of
a generic drug in a new patent-pending formulation, and introduce it
to the US market. A person at the FDA said that it would be a 505 b-2
application. The formula is currently in research trials in Europe.

I would like someone to outline the process needed for approval in the
US. I am more concerned with the time frame, and how much research is
needed in the US, than with the cost of research.
There is no answer at this time.

There are no comments at this time.

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