We are not saying we are confident these drugs will not cause liver toxicity,

the highest standards in the world for approving drugs.

We are now confident that patients have safer alternatives in this important class of diabetes drugs,

There's a bottleneck getting drugs to people and we may now be able to test thousands of compounds that would not have been evaluated under the prior method.

We think this will provide more rapid development and approval of vaccines.

The rule we will be publishing today represents the first major overhaul of the format and content or prescribing information in 25 years. With this step, the FDA believes we are driving into the information age, out of the 20th century and into the 21st century. These changes will not only enable better access to paper information but will enable the revolution in electronic prescribing information.