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.