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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 12, 2017 Category: American Health Source Type: blogs
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” … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 11, 2017 Category: American Health Source Type: blogs
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 7, 2017 Category: American Health Source Type: blogs
‘Fight BAC:’ FDA’s Little Green Monster Still Going Strong After 20 Years
By: John Swann, Ph.D. Twenty years ago, FDA was invaded by a hideous creature that today is still one of the most unforgettable and endearing artifacts in the FDA History vault. The giant green character (who came to life thanks … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 6, 2017 Category: American Health Source Type: blogs
FDA Working to Lift Barriers to Generic Drug Competition
By: Scott Gottlieb, M.D. Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 21, 2017 Category: American Health Source Type: blogs
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 17, 2017 Category: American Health Source Type: blogs
Fostering Medical Innovation: A Plan for Digital Health Devices
By: Scott Gottlieb, M.D. 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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 15, 2017 Category: American Health Source Type: blogs
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 14, 2017 Category: American Health Source Type: blogs
In cancer treatment, there ’s more than one way to measure patient benefit
By: Richard Pazdur, M.D. We all want a cure for cancer. But the reality is that advances in cancer treatment rarely come in one big discovery, but rather with the continued step-by-step progress in developing new therapies. Currently, a few … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 1, 2017 Category: American Health Source Type: blogs
#IAmHHS: Fighting Misleading Prescription Drug Ad Claims
By: Mike Sauers These days, you can hardly turn a magazine page, watch a TV show or sit in the lobby of your doctor’s office without seeing advertising and promotions for prescription drugs. They’re everywhere you go. And they tend … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 1, 2017 Category: American Health Source Type: blogs
A Year Later, FDA Is Better and Stronger in Protecting Consumers from Unsafe Foods
By: William Correll and Douglas Stearn We have made dramatic changes in our response to complex, potentially high-risk food safety situations that may be difficult to address quickly. Almost a year ago, we heard concerns that FDA was not doing … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 24, 2017 Category: American Health Source Type: blogs
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 23, 2017 Category: American Health Source Type: blogs
FSMA Collaborative Training Forum: ‘Educate Before and While We Regulate’
By: Donald Kautter Jr. and Stephen Hughes “We will educate before and while we regulate.” That’s been a mantra for FDA as the rules that implement the FDA Food Safety Modernization Act (FSMA) have taken shape. Making sure that food … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 23, 2017 Category: American Health Source Type: blogs
‘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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 18, 2017 Category: American Health Source Type: blogs
Reducing Preventable Harm from Medications: Too Big for FDA to Do Alone
By: John J. Whyte, M.D., M.P.H. Sometimes a drug can be used exactly as FDA approved it, taken just the way a doctor prescribed it, and a patient can still experience adverse events. When it comes to drugs, not all … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 16, 2017 Category: American Health Source Type: blogs
