We get 40 to 50 first-generic submissions a year, and we make quick decisions and approvals on them, often on the same day the patent or exclusivity expires.

We accept submissions by April 15 of every year.

It seems like you have to make decisions earlier every year. When I first started farming, we wouldn't buy seed until a couple of weeks before planting. Now we find ourselves working on that during the harvest.

I've got to make decisions. I've got to make quick decisions. I can't manufacture something.

The generic-drug program is very important to the F.D.A..

We believe that giving consumers a choice of safe, effective and reasonably-priced alternatives is extremely important to the economy and well-being of the American public.