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.

POTUS gets a Warning Letter
If a pharmaceutical company actively promotes one of its products for conditions other than those approved by the Food and Drug Administration, it ’s considered “violative behavior” and often results in what’s known in the regulatory world as a “warning letter” -- official correspondence from the FDA ordering the firm to cease and desist from such communications. But can the FDA send a warning letter to the President of the United States? (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - April 6, 2020 Category: Pharmaceuticals Source Type: blogs

Expert: NC better positioned than other states to respond to pandemic (WRAL)
The slow growth in coronavirus cases in North Carolina relative to New York and some other states puts North Carolina in better position to respond to the pandemic, according to a Duke University professor. Economist Mark McClellan, the director of the Duke-Margolis Center for Health Policy, was U.S. Food and Drug Administration commissioner during the […] The post Expert: NC better positioned than other states to respond to pandemic (WRAL) appeared first on Peter Ubel. (Source: blog.bioethics.net)
Source: blog.bioethics.net - April 3, 2020 Category: Medical Ethics Authors: peter Tags: Health Care health policy Peter Ubel syndicated Source Type: blogs

FDA Bureaucracy Grows 79% Since 2007
Chris EdwardsThe Food and Drug Administration (FDA) oversees the safety of human and veterinary drugs, biological products, medical devices, foods, cosmetics, and products that emit radiation. The agency also regulates the manufacturing and marketing of tobacco.During the COVID-19 crisis, the FDA has been more of a hindrance than a help. It put the battle weeks behind byblocking the development of private ‐sector virus tests, and its regulations have slowed production ofhand sanitizer andfacemasks.I notedthe other day that FDA employment has soared since 2007. What do all the new employees do? The table below shows...
Source: Cato-at-liberty - April 3, 2020 Category: American Health Authors: Chris Edwards Source Type: blogs

From Spirits to Sanitizer
Jeffrey Miron andErin PartinExtreme circumstances often inspire innovation. One current example is the pivot by distillers from making spirits tomaking hand sanitizer.The transition was not without government hurdles, but in this instance government cooperated with common sense. First, the Alcohol and Tobacco Tax and Trade Bureau waived requirements to obtain permits in order to legally manufacture hand sanitizer and agreed to waive the federal excise tax for alcohol ‐based hand sanitizer products. In addition, the Food and Drug Administration issuedtemporary guidance saying, “the agency does not intend to take...
Source: Cato-at-liberty - March 24, 2020 Category: American Health Authors: Jeffrey Miron, Erin Partin Source Type: blogs

Coronavirus, Chloroquine, and “Off‐label” Use
Jeffrey A. SingerAt a Coronavirus Task Force briefing last week, President Trumpincorrectly told the press that the antimalarial drug chloroquine had already gone through the Food and Drug Administration ’s approval process for the treatment of COVID-19 infection:“They’ve gone through the approval process, it’s been approved and they did it, they took it down from many, many months to immediate.” He was later corrected by the FDA Commissioner, who said the approval process had not and will not be completed until controlled clinical trials have convin ced the agency.Many people might therefore conclude that d...
Source: Cato-at-liberty - March 23, 2020 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Is Tomosynthesis Better than Mammography at Detecting Breast Cancer?
New research shows digital breast tomosynthesis (DBT) to be a more effective breast cancer diagnosis tool than digital mammography (DM), according to a study recently published inRadiology. DBT is a relatively new screening practice and was only approved by the Food and Drug Administration in 2017. It uses an x-ray tube that glides in an arc-shape and uses low levels of radiation to image the breast from various angles. Up until now, research only showed us how effective the screening is in the first round of testing before detection rates are expected to escalate. Those early studies showed that DBT had higher detection ...
Source: radRounds - March 21, 2020 Category: Radiology Authors: Julie Morse Source Type: blogs

Coronavirus and Regulation
Thomas A. Firey andPeter Van DorenCrises often illuminate “inefficient” public policies—ones with costs that outweigh their benefits. Society can tolerate (and may not even notice) them in ordinary times, allowing the policies to continue and protect and enrich special interests. But in crises, their costs become less tolerable.Because of the coronavirus, the U.S. economy is experiencing simultaneous negative shocks todemand andsupply. The demand shock is broadly understood: “social distancing” is causing people to avoid (and governments to close or curtail) mass transit, restaurants, personal services, and other...
Source: Cato-at-liberty - March 20, 2020 Category: American Health Authors: Thomas A. Firey, Peter Van Doren Source Type: blogs

Digital Twins and the Promise of Personalized Medicine
Can you guess the percentage of patients with Alzheimer’s on whom medication is ineffective? What about those with arthritis? Or cardiac arrhythmia? In fact, you don’t have to guess as the US Food and Drug Administration (FDA) already has the answers: 70%, 50% and 40% respectively. The percentage of patients for whom medications are ineffective range from 38-75% for varying conditions from depression to osteoporosis. The main cause is because of the very genetic makeup of every individual. The latter is so different and their interaction so unique that therapies for the “average patient” might very well no...
Source: The Medical Futurist - March 19, 2020 Category: Information Technology Authors: Prans Tags: Future of Medicine Personalized Medicine digital health technology healthcare data digital twin technology design Source Type: blogs

Drive-Through Collection of Samples for COVID-19 Testing in Cleveland
The notion of drive-through to collect nasal swabs for COVID-19 testing is a practical and efficient idea and, I think, will ultimately be used across the country. Here's an article about how such a collection process is being organized by two Cleveland hospitals (see:University Hospitals and Cleveland Clinic Partner to Provide Drive-Through COVID-19 Testing). Below is an excerpt from the article:Cleveland Clinic and University Hospitals (UH) have partnered to provide drive-through COVID-19 testing for patients with a doctor ’s order from UH or Cleveland Clinic....Patients without a doctor ’s order will not b...
Source: Lab Soft News - March 17, 2020 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Clinical Lab Testing Cost of Healthcare Diagnostics Food and Drug Administration Healthcare Innovations Lab Industry Trends Lab Processes and Procedures Preventive Medicine Source Type: blogs

Opioid Medication For Addiction Treatment
For many individuals, “cold-turkey” abstinence isn’t realistic when it comes to recovering from addiction. This is especially true when it comes to opioid addiction. Opioids take over the brain’s chemistry so much to the point that it can be difficult to function without it. Therefore, taking opioid medication for addiction treatment in medication-assisted treatment has been found to help individuals recovering from opioid addiction by reducing the withdrawal symptoms and allowing for their body to readjust. Medication-Assisted Treatment Medication-assisted treatment is the use of medications in combination with c...
Source: Cliffside Malibu - February 25, 2020 Category: Addiction Authors: Jaclyn Uloth Tags: Detox Resources for Alcohol and Drugs/Opiates Medical medical detox medicated-assisted detox medication opioid opioids prescription medication Source Type: blogs

What Will the US ‐China Deal Accomplish on Tech Transfer, IP Protection and Innovation?
Simon Lester andHuan ZhuTheUS-China Economic and Trade Agreement, described as a " phase one " deal, entered into force today (30 days after signature, pursuant to Article 8.3, para. 1). The Agreement has created a temporary tariff truce. For the time being, it seems that tariffs will not be raised further, and both sides lowered their retaliatory tariffs to some extent, which is good news.But with all the talk of tariffs, it is easy to lose sight of the U.S. concerns about Chinese trade practices. How does the Agreement do in terms of addressing the purported basis for the trade war?The trade war began with a Section 301 ...
Source: Cato-at-liberty - February 14, 2020 Category: American Health Authors: Simon Lester, Huan Zhu Source Type: blogs

Why Health Care Organizations Need Technology Ethics Committees
There is big money in using technology to find information in patient and medical staff data. Companies are rushing to cash in. The Food and Drug Administration has approved more than 40 artificial intelligence-based products for use in medicine. Tens of thousands of medical phone apps are tracking patients and gathering detailed medical information about them. These new technologies bring new ethical questions that health care organizations are poorly equipped to answer. The post Why Health Care Organizations Need Technology Ethics Committees appeared first on The Hastings Center. (Source: blog.bioethics.net)
Source: blog.bioethics.net - February 5, 2020 Category: Medical Ethics Authors: Susan Gilbert Tags: Ethics Health Care apps artificial intelligence Hastings Bioethics Forum Health and Health Care health care technology syndicated Source Type: blogs

Be careful where you get your news about coronavirus
News about a deadly virus that appeared in Wuhan, China in December (now called 2019 novel coronavirus, or 2019-nCoV) is everywhere lately. And as the number of cases rises, it’s understandable if you’re wondering how likely it is that you or a loved one will become ill. And quite likely, you’re also wondering how to prevent this. So, where should you turn for the latest information on a rapidly changing situation? It’s hard to beat the convenience of the internet, and we know there’s a lot of useful and reliable information online. But there’s also a lot of misinformation. The trick is to figure out which is w...
Source: Harvard Health Blog - February 1, 2020 Category: Consumer Health News Authors: Robert H. Shmerling, MD Tags: Cold and Flu Emergency Planning Health Infectious diseases Travel health Source Type: blogs

Medically Assisted Treatment for Alcohol
Going through alcohol withdrawal can be an uncomfortable experience. Fortunately there are medical interventions that can ease the symptoms of detox as well as help individuals along their journey through recovery. Medically assisted treatment (MAT) is the use of medications in combination with counseling and behavioral therapies, which is effective in the treatment of substance abuse and can help some people to sustain recovery. Medically assisted treatment for alcohol can help people recovering from alcohol use disorder by blocking cravings, avoiding relapse, and helping to rewire the brain’s chemistry. Medications Us...
Source: Cliffside Malibu - January 24, 2020 Category: Addiction Authors: Jaclyn Uloth Tags: Alcohol Alcohol Rehab Information Alcoholism Detox Resources for Alcohol and Drugs/Opiates alcohol detox drug detox medical detox medicated-assisted detox Source Type: blogs

Discover Which CSD Stories Topped the Charts in 2019
A lot happened in the world of communication sciences and disorders in 2019. The U.S. Food and Drug Administration approved cochlear implants for single-sided deafness. Skilled nursing facilities reacted to Medicare reimbursement changes in an unexpected and unfortunate way. A video clip showing comedian D. J. Pryor “talking” with his baby son went viral and demonstrated the benefits of communicating with your child to millions. People with communication disorders made more appearances on big and little screens. One of those featured was a child with a cochlear implant in Pixar’s Toy Story 4. We covered these events ...
Source: American Speech-Language-Hearing Association (ASHA) Press Releases - January 6, 2020 Category: Speech-Language Pathology Authors: Shelley D. Hutchins Tags: Academia & Research Audiology Health Care News Private Practice Schools Slider Speech-Language Pathology Hearing Assistive Technology Professional Development Source Type: blogs