The generic-drug program is very important to the F.D.A.. |
We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog. |
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. |
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. |