You had the same requirements for huge plants making millions of doses and for the production of tiny doses for initial human use.

234

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

228

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

220

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.

203

We hope we'll revolutionize safety and the ability to use medications in the best way possible.

196

You would expect with all the new science, we'd become more efficient and more productive.

196

We are making the prescribing information much more targeted and useful for physicians.

189

We see this as a platform whereby we can build much better consumer information. This is just one step in getting better prescribing information to the people who need it.

188

Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies.

134

You might have a smaller number of animal species, perhaps one instead of two.

126

We are making the prescribing information much more targeted and useful for physicians. The prescribing information over the years, as we learned more and more about medicines, has become very congested and complex. We've heard from physicians it's hard for them to find the information they need.

124

The FDA is reforming its whole approach to manufacturing, trying to modernized manufacturing. We hope to stimulate scientific discovery. We think this will help translate new discoveries into the hands of patients.

116

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

107

The highest standards in the world for approving drugs.

104

We really need to incorporate more modern science into the process. We have this tremendous science in the lab discovering new innovations that would help people, but the process for development is actually what we did 100 years ago.

89