FDA’s role in medical device cybersecurity

Dr. Suzanne Schwartz, FDA Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate in can be vulnerable to security breaches. A computer virus or hack resulting in the loss of

The Mammography Quality Standards Act: A 25-year public health success story

By: Dr. Helen Barr Mammography has been widely used as a screening tool to detect early-stage breast cancer since the mid-1960s. As the use of the technology expanded it became clear that there were wide variations in the quality of the mammograms and the dose being delivered to patients. Following a series of hearings, Congress stepped

Expanded Access: FDA describes efforts to ease application process

By: Scott Gottlieb, M.D. FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational drugs and devices to patients with serious

How FDARA is making a difference for industry and patients

Drs. Peter Marks, Jeffrey Shuren, and Janet Woodcock, FDA For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon. Since passage of the first medical product

China joins ICH in pursuit of global harmonization of drug development standards

Theresa M. Mullin, FDA 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 Administration

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

Dr. Scott Gottlieb 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 remain

How FDA is promoting safety, quality in clinical trials done in India

Dr. Leslie Ball; Letitia Robinson, PhD, RN; and Dr. Elizabeth Wiley 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, the vast Mumbai

2 recent scientific advances suggest encouraging future for precision medicine

Dr. Janet Woodcock 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 of

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

Dr. Jeffrey Shuren and Dr. Bram Zuckerman 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) was no