Food and Drug Administration (FDA) Blogs This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

CDC Extols the Benefits of Naloxone ⁠—Time to Make it OTC
Yesterday the Centers for Disease Control and Prevention reported that while naloxone prescriptions have increase 106 percent in the last year, the increase has been spotty, and largely confined to urban areas. Columbia University epidemiologist Katherine Keyes told the Los Angeles Times that she suspects the increase in naloxone distribution is contributing to what appears to be a stabilization of the opioid-related overdose rate in 2018. I agree, as I have written here. Distributing the opioid overdose antidote naloxone is one harm reduction measure that has gained widespread acceptance among policy makers, despi...
Source: Cato-at-liberty - August 7, 2019 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Trump Plan For Pharmaceutical Importation A Small Step In The Right Direction
On July 31 Secretary of Health and Humans Services Alex Azar announced a proposal that would allow US pharmacies, distributors, and states to import drugs from Canada that are sold there by US drug makers at prices well below the prices for which they are sold in the U.S. US pharmaceutical companies sell many of their products at much lower prices demanded by Canada’s central health ministry called Health Canada. The Secretary was authorized to implement this proposed policy by theMedicare Modernization Act of 2003.This idea has been long opposed by US pharmaceutical companies. They argue that the Food and Drug Admini...
Source: Cato-at-liberty - August 1, 2019 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

New FDA-approved weight loss device shows promise
Obesity is a disease that currently affects our population in epidemic proportions, and which has a profound effect on health and quality of life. As a physician dedicated to the prevention and treatment of the medical complications of excess weight, I frequently see patients whose efforts at restricting calories and increasing physical activity are not resulting in sustained weight loss. When that’s the case, particularly if the excess weight is causing health issues, we can consider adding other treatment tools, which include weight loss medications, or weight loss surgeries. And while these options have increased dram...
Source: Harvard Health Blog - July 29, 2019 Category: Consumer Health News Authors: Florencia Halperin, MD Tags: Diet and Weight Loss Health Healthy Eating Source Type: blogs

FDA Approves Bayer GBCA for Coronary Artery Disease
This week, the Food and Drug Administration (FDA) gave the green light approval to Bayer AG ’s gadobutrol (Gadavist), a gadolinium-based contrast agent (GBCA) used in cardiac MRI procedures for patients with known or suspected coronary artery disease. It’s the first and only approved agent for this type of procedure. “We now have an approved contrast agent for use in cardiac MRI to assess perfusion and late gadolinium enhancement in less than 1 hour, ” saidScott Flamm, MD who co-authored a statement on using the GBCA in myocardial perfusion studies. Gadavist is also used to evaluate the blood supply to the heart...
Source: radRounds - July 19, 2019 Category: Radiology Authors: Julie Morse Source Type: blogs

Price-Fixing Case Reveals Vulnerability of Generic Drug Policies
By ANDREW MULCAHY A massive lawsuit filed in May by 44 states accuses 20 major drug makers of colluding for years to inflate prices on more than 100 generic drugs, including those to treat H.I.V., cancer and depression. If true, the alleged behavior is not just a violation of antitrust law, but also a betrayal of the government policies that created and defended the entire generic drug industry. Most prescriptions in the U.S. today — 9 in 10 — are filled with generics, which are just as safe and effective as their brand-name equivalent. And yet generics account for only 22 percent of U....
Source: The Health Care Blog - July 12, 2019 Category: Consumer Health News Authors: Christina Liu Tags: Uncategorized Andrew Mulcahy drug price controls Drug Pricing generic drugs pharmaceuticals price-fixing Source Type: blogs

Senators Manchin and Braun Are Attempting to Practice Medicine Without a License —And Fighting the Wrong War
Senator Joe Manchin (D-WV) and Mike Braun (R-IN) are still trying to address the fentanyl and heroin overdose crisis —soon to be joined by a methamphetamine and cocaine overdose crisis—by denying chronic pain patients access to pain relief. They have just introduced a bill they call The FDA Opioid Labeling Accuracy Act, which would “prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of ‘around-the-clock, long-term opioid treatment’ until a study can be completed on the long-term use of opioids.”Set aside the fact that most pain specialists agree that, in some...
Source: Cato-at-liberty - July 12, 2019 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

BraveHeart Wireless Announces FDA Clearance of the BraveHeart Life Sensor Cardiac Monitoring System
• The BraveHeart Life Sensor Cardiac Monitoring system has been cleared for use in health care settings. • The Life Sensor monitoring system securely captures patients’ heart rate and EKG data, and transmits the data to health care providers in real time. • More than 28 million Americans diagnosed with heart disease may benefit—with this number growing each year. NASHUA, New Hampshire — June 19, 2019 — BraveHeart Wireless Inc., a leading innovator in clinical-quality biometric wearables, today announced that the company received clearance from the U.S. Food and Drug Administration (FDA) for the ...
Source: Medgadget - July 1, 2019 Category: Medical Devices Authors: Laurie Dove Tags: Cardiology Sponsored Content Source Type: blogs

The Water Purifier Insights
You're reading The Water Purifier Insights, originally posted on Pick the Brain | Motivation and Self Improvement. If you're enjoying this, please visit our site for more inspirational articles. What types of impurities are filtered by the different types of filters? Things to be considered before buying a water filter. FILTERS OF A WATER FILTER Freshwater is a limited resource, so every kind of water available isn’t fit for drinking. Factors like the growing population and environmental degradation are mainly responsible for this. So we need to know the various purification techniques available in the mar...
Source: PickTheBrain | Motivation and Self Improvement - June 20, 2019 Category: Consumer Health News Authors: albert Tags: Uncategorized Source Type: blogs

Beware the claims of stem cell clinics
Earlier in June, the U.S. Food and Drug Administration (FDA) won a major legal victory by getting an injunction to prevent Florida-based US Stem Cell Clinic from offering its treatments. The company claimed to create stem cells from patients ’ body fat and use these to treat a variety of serious illnesses, including Parkinson’s disease, ALS, […]Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - June 16, 2019 Category: General Medicine Authors: < span itemprop="author" > < a href="https://www.kevinmd.com/blog/post-author/edward-hoffer" rel="tag" > Edward Hoffer, MD < /a > < /span > Tags: Conditions Neurology Source Type: blogs

You Can ’ t Suppress the Data
As we are all learning, if you try and suppress research data, you’re ultimately going to fail. Especially if you’ve previously made such data available to the U.S. Food and Drug Administration, or even discuss the data in an email. Companies need to be ready to come clean with even negative data about their products, because only the complete picture will be considered by the people prescribed your product. A company has to make a decision — forfeit some profit in the short-term and acknowledge their drug isn’t the best thing since sliced bread, or forfeit lots of reputation, trust and brand value ...
Source: World of Psychology - May 24, 2019 Category: Psychiatry & Psychology Authors: John M. Grohol, Psy.D. Tags: General 1980s 1990s 31 Million Antipsychotic Drug Astrazeneca Atypical Antipsychotic Best Thing Since Sliced Bread Brand Strategy Food And Drug Food And Drug Administration Johnson Johnson Mcneil Mental Health Trust Parent Comp Source Type: blogs

Millions Take Gabapentin for Pain. But There ’s Scant Evidence It Works. - The New York Times
One of the most widely prescribed prescription drugs, gabapentin, is being taken by millions of patients despite little or no evidence that it can relieve their pain.In 2006, I wrote about gabapentin after discovering accidentally that it could counter hot flashes.The drug was initially approved 25 years ago to treat seizure disorders, but it is now commonly prescribed off-label to treat all kinds of pain, acute and chronic, in addition to hot flashes, chronic cough and a host of other medical problems.The F.D.A. approves a drug for specific uses and doses if the company demonstrates it is safe and effective for its intend...
Source: Psychology of Pain - May 22, 2019 Category: Anesthesiology Source Type: blogs

Still Negative on Watchman
Many readers have contacted me to ask whether my negative viewson left atrial appendage occlusion with Watchman have changed since 2017. The short answer is no. My views are even more negative today. In 2016, I published an editorial on theHeart.org | Medscape Cardiology arguing that this procedure should stop. One of the rebuttals was that it was a blog post, not an academic editorial. Months later, Andrew Foy, Gerald Naccarelli and I put the same argument into academic-speak and the influential journal Heart Rhythm published it.[1] I have debated and presented this topic multiple times ...
Source: Dr John M - May 17, 2019 Category: Cardiology Authors: Dr John Source Type: blogs

Grail Picks Specific Method for Liquid Biopsy Clinical Trials
Discussion about the"Liquid Biopsy";"Liquid Biopsy" Used to Refer to Detection of Any Serum Cancer DNA). Initially, the test involved the isolation of circulating cancer cells from a blood sample, a daunting task due to their rarity, and the subsequent analysis of the DNA of them. Liquid biopsy research has evolved since then to the collection and analysis of cell-free circulating DNA and RNA. A recent article discussed howGrail, the apparent leader in the commercialization of the technology, has selected what it deems to be the best method for cancer detection in the blood (see:Grail, the liquid biopsy...
Source: Lab Soft News - May 15, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Clinical Lab Industry News Clinical Lab Testing Diagnostics Food and Drug Administration Genomic Testing Healthcare Innovations Lab Industry Trends Lab Processes and Procedures Medical Research Predictive Analytics Preventive Medicine Source Type: blogs

Six-Lead, Consumer-Facing ECG Device Close to Release to Market
I have previously blogged aboutAliveCor's three-lead ECG device in particular and cardiology in general as examples of cardiology being a"collision point" between consumer IT and the healthcare system (see:Three New Studies Confirm Clinical Utility of AliveCor ’s KardiaMobile Device and AI Algorithms;Cardiology as a"Collision Point" between Consumer IT and the Healthcare System). The company is now testing a a six-lead ECG instrument (see:AliveCor previews next product: A 6-lead smartphone ECG). Here is an excerpt from this article:AliveCor, which has offered an smartphone-connected ECG sinc...
Source: Lab Soft News - May 11, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Diagnostics Food and Drug Administration Healthcare Information Technology Healthcare Innovations Medical Consumerism Medical Research Preventive Medicine Test Kits and Home Testing Source Type: blogs