By: Theresa M. Mullin, Ph.D. Increasingly, drug development is a global endeavor. It requires international collaboration to ensure that consistent standards are adopted and adhered to by all drug makers and regulatory authorities, regardless of country of origin or destination. I am pleased to have been in China recently, when the China Food and Drug […]
FDA Voice
FDA announces new steps to empower consumers and advance digital healthcare
By: Scott Gottlieb, M.D. When people think about personalized medicine, they often think of genetic testing and sequencing of the human genome. But the concept of personalized medicine is much broader. It includes the re-imagination of healthcare delivery. It includes empowering consumers to take more control of their own healthcare information to make better informed […]
Patient Reps: Bringing the voice of patients to FDA
By: Jack Kalavritinos At FDA we never lose sight of the fact that the work we do in evaluating and approving new medical products is done to benefit patients. Increasingly, that means taking into account the views and expertise of patients and their caregivers, because they provide a unique voice and perspective and know best […]
FDA sets inaugural meeting of first-ever Patient Engagement Advisory Committee
By: Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D. Imagine checking your blood sugar levels several times a day with a glucose meter to keep your diabetes under control. Or maybe you’ve had a hip joint replaced or a stent inserted in your coronary artery to treat a heart blockage. Maybe you participated in a clinical […]
Building a strong FDA workforce to bring scientific advances to patients
By: Scott Gottlieb, M.D. The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, is the technical, scientific, and clinical expertise of its people. As the products that we’re asked to review become more complex and specialized, so do the technical demands on our workforce. Our staff must […]
FDA collaborates to promote safety, quality in clinical trials done in India
By Leslie Ball, M.D., Letitia Robinson, Ph.D., R.N, and Elizabeth Wiley, M.D., J.D., M.P.H. After more than 16 hours of travel, we touch down in Mumbai late in the evening and are greeted by a wave of heat and humidity as we exit the airport terminal. As we drive from the airport to the hotel, […]
Two recent scientific advances underscore an encouraging future for precision medicine at FDA
By: Janet Woodcock, M.D. FDA helps bring precision medicine – in the form of targeted therapies — to people living with diseases that have specific genetic features. Two recent FDA drug approvals point to an encouraging future for “precision medicine” — an approach for disease treatment that tailors medical therapies, including medications, to the needs […]
How FDA plans to help consumers capitalize on advances in science
By: Scott Gottlieb, M.D. We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being […]
FDA Science: Working at the speed of emerging technologies
By Luciana Borio, M.D. Let’s face it, we’ve all gotten used to nearly instant access to almost anything. Today, with a tap of an app, we order a car ride, a book, or pizza for dinner. Need to navigate past traffic in downtown city streets? No problem. There’s an app for that, too. Some may […]
Digital health devices: FDA’s plan for innovation
Dr. Scott Gottlieb, FDA commissioner It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can […]
How creative FDA regulation led to first-in-the-world approval of a cutting-edge heart valve
By: Jeffrey Shuren, M.D., J.D., and Bram Zuckerman, M.D. Nearly six years ago FDA approved an artificial transcatheter heart valve (THV) to treat patients having severe symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest, because one of the valves in their heart (the aortic valve) […]