What is Regulatory Science? (video-full version)
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What is Regulatory Science? (video-full version)


What is Regulatory
Science? There are many
definitions of science. But what does
it mean to you? How does it affect how
you and your family live? One kind of science that
touches your daily life, and is the foundation of
everything we do at the Food and Drug
Administration… …is called
regulatory science. Regulatory science
sounds complicated. But it is actually
pretty straightforward. It is really about
developing the knowledge, tools, standards and
approaches that will help us do our job better. Thanks to regulatory
science at FDA, you can expect that the drugs your
doctor prescribes – or the contact lenses you wear –
are as safe and effective as you expect them to be. The same goes for the food
you buy at the grocery store. That it’s… …safe and is the quality
you want for yourself and for your family. That’s why you should care
about regulatory science. When most people think
about medical research and science, they think about
the scientists discovering new genes, proteins,
networks or cells that are involved in maintaining
health or propagating disease. But most people don’t
think about or appreciate all of the science and
innovation that it takes to turn these discoveries
into a new therapy for patients, or to understand
how well these therapies work in larger populations
or to evaluate the safety, effectiveness and quality
of these products. This science is
regulatory science. …you should be concerned
about regulatory science because it keeps
your food safe. For example, FDA is using
whole genome sequencing – much like the FBI uses
it in tracking down criminals, we use it to
track down pathogens. And we do that because it
forms a fingerprint for the pathogen that lets
us keep your food safe. We can trace the rare
occasions of illness with salmonella or listeria
or other deadly food pathogens more quickly,
back to the source, keeping your food safe, so
that when you go into a restaurant or you go into
a grocery store, you can be assured that
that food is safe. We should all care about
regulatory science because it’s an important part of
developing new medicines for important diseases
like Alzheimer’s, cancer and diabetes. First, it helps us to
identify what patients are likely to benefit from the
uses of new medicines, help us identify those
benefits earlier, with better precision. We’ve recently been able
to use regulatory science to identify what patients
with viral hepatitis and certain kinds of cystic
fibrosis are going to benefit from the uses of
new medicines, and approve those medicines. Second, regulatory science
is giving us new tools to predict the safety of
drugs earlier, so that adverse effects don’t
happen to patients, and if they do, they can be
treated more quickly. I’m excited about
regulatory science and the promise it holds
for public health. We’re involved in working
with an artificial arm. The conventional
artificial arm can lift an object, can hold an
object, but the patient isn’t feeling anything. If we can get an arm that
also gets sensory feedback that tells the patient
– “is it a hard object? Is it a soft object?” that’s going to really
enhance their life and their ability to interact
with the physical world. To do that, we need
to have a way for the artificial limb to talk
directly to the brain. We’re involved in research
that ensures that that connection is stable,
and that the signals are noise-free, and that
last for the life of the patient. If we can achieve that
level of connection of the artificial limb to the
brain, patients that have lost a limb or who have
had an injury, will have a much better quality of
life – and for me, that’s very exciting. Our growing understand
of the human genome has opened new horizons
for understanding the mechanisms of disease, for
developing new diagnostic tests to uncover the cause
of individual patients symptoms, and for
developing new medical products targeted to
specific causes of illness. This is the heart of
“personalized medicine”. The right dose of – the
right drug for – the right indication for –
the right patient. Regulatory science helps
us convert great ideas into practical approaches
to speed the development of new products, to assure
the safety and efficacy of those products, and to
improve the diagnosis and treatment of all patients. We call it
regulatory science. But whatever you call it,
it is making a difference in all our
lives every day. So, find out more about
why you should care about regulatory science
on our FDA website!

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