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) […]
FDA Voice
Statement from FDA Commissioner on opioid drugs with abuse-deterrent properties
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new […]
FDA Commissioner asks staff for ‘more forceful steps’ to stem the opioid crisis
By: Scott Gottlieb, M.D. As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases […]
‘Radiating Shoe Sales’
By: Vanessa Burrows Since the discovery of X-rays in the late 19th century, the technology has enhanced health care in a variety of ways. Like many cutting-edge scientific developments, however, it also has inspired uses of uncertain therapeutic value. That was the case with the shoe-fitting fluoroscope, the subject of the latest episode of FDA’s […]
Dr. Gottlieb’s first remarks to FDA staff
Remarks by Scott Gottlieb, M.D. FDA All Hands Meeting May 15, 2017 Silver Spring, MD It’s an honor to be here today and to be taking on this responsibility with all of you. You realize how special our mission of consumer protection and public health promotion is when you explain what we do to the children […]
FDA and NIH release final template for clinical trial protocols
By: Peter Marks, M.D., Ph.D. A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final […]
Working to raise awareness and reduce health disparities
By: Jonca Bull, M.D. April is National Minority Health Month and this year’s theme is “Bridging Health Equity Across Communities.” FDA’s Office of Minority Health (OMH) is committed to the HHS mission of advancing health equity, and our office works year-round to advance FDA’s message of ensuring the safety and efficacy of our nation’s food […]
Improving the safety of imported foods through partnerships
By: Susan Mayne, Ph.D., Camille Brewer, M.S., R.D., and Donald Prater, D.V.M. At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods they choose to serve their families. In passing the FDA Food Safety Modernization Act (FSMA), […]
America’s Got Talent – regulatory science style
By: Stephen Ostroff, M.D. Veni Vidi Vici. It translates into English as “I came, I saw, I conquered.” It also happens to be the name chosen by one of the winners of the recently held America’s Got Regulatory Science Talent Competition. FDA recognizes that young scientists are our future. Now in its fifth year, America’s Got Regulatory […]
‘Organs-on-Chips’ technology: FDA testing groundbreaking science
By: Suzanne Fitzpatrick, Ph.D. There are many things you might envision putting on a chip. It’s unlikely that a human organ is one of them. But creating human organ systems in miniature on micro-engineered chips about the size of a AA battery is a revolutionary testing technology that has captured the attention of food scientists […]
