(11 quotes found)
“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. Janet Woodcock
“You had the same requirements for huge plants making millions of doses and for the production of tiny doses for initial human use.”
“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.”
“You might have a smaller number of animal species, perhaps one instead of two.”
“This will allow us to test a broader variety of compounds in people early and then pick the best one for taking forward.”
“We are making the prescribing information much more targeted and useful for physicians.”
“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.”
“Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies.”
“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.”
“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.”
