Dr. Woodcock Quotations

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

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.

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

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.

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

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.

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

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.

It seems like, to many of us, that tremendous opportunities are being wasted right now because trials are being done, and those trials could be used as vehicles to study and qualify biomarkers.