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.
More Quotes from Dr. Woodcock:
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.Dr. Woodcock
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.
Dr. Woodcock
Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies.
Dr. Woodcock
You might have a smaller number of animal species, perhaps one instead of two.
Dr. Woodcock
This will allow us to test a broader variety of compounds in people early and then pick the best one for taking forward.
Dr. Woodcock
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