This will allow us to test a broader variety of compounds in people early and then pick the best one for taking forward.

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.

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.

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

This is particularly important for academic researchers who are seeking to find out if discoveries in the laboratory actually have promise in people. Now we can learn tremendous amounts of information without exposing people to very high doses.