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.

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

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.

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,

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