Food and Drug Administration (FDA)

See the following -

The Threat From Antibiotic Use On The Farm

Donald Kennedy | The Washington Post | August 22, 2013

When I was commissioner of the U.S. Food and Drug Administration (FDA), the agency’s national advisory committee recommended in 1977 that we eliminate an agricultural practice that threatened human health. Routinely feeding low doses of antibiotics to healthy livestock, our scientific advisory committee warned, was breeding drug-resistant bacteria that could infect people. Read More »

They’re Feeding WHAT To Cows?

Brad Jacobson | OnEarth | December 12, 2013

'Poultry litter' is exactly what it sounds like: the filthy stuff scraped off the floor of a chicken coop. Feeding it to cattle (yes, that happens) risks the spread of mad cow disease—yet the FDA has done nothing to stop it. Read More »

This Actually Is a Test

When it comes to health care, testing is not what it used to be, or what it is going to be in the not-too-distant future. For example, confirmation of a cancer diagnosis is getting much easier.  The New York Times reported that blood tests -- known as "liquid biopsies" -- have now been shown to generally match the results of a tumor biopsy.  The blood tests look for DNA fragments from the tumor that signal its presence.  The liquid biopsies are useful for both detecting the presence of a tumor and its ongoing monitoring. The current generation of tests are not perfect, with as many as 15% of tumors not generating enough DNA to be detected, but they do offer the advantage of not requiring an invasive procedure...

Threat Matrix: Malware And Hacking Pose Dangers To Medical Devices

Mike Miliard | Healthcare IT News | May 24, 2013

'We’re starting to attach medical devices to electronic health records, and they’re not secure.' Read More »

Three Areas Where Health Information Technology Needs to Get its House in Order

Health reform is taking off, thanks to pressure from insurers, the promise with which innovative technologies tease us for low-cost treatments, and regulatory mandates dating back to the HITECH act of 2009. Recent hopeful signs for wider adoption of health technologies include FDA forebearance from regulating consumer health apps, calls for more support for telemedicine, and new health announcements from tech giants such as Apple and Google. While technologists push forward in all these areas, we need to keep in mind that several big unsolved problems remain. Let's not get lost in the details--these major issues have to be tackled head on. Read More »

To Err Is Human, To Diagnose Artificial Intelligence is...?

A new study found that physicians have a surprisingly poor knowledge of the benefits and harms of common medical treatments.  Almost 80% overestimated the benefits, and two-thirds overestimated the harms.  And, as Aaron Carroll pointed out, it's not just that they were off, but "it's how off they often were." Anyone out there who still doesn't think artificial intelligence (AI) is needed in health care? The authors noted that previous studies have found that patients often overestimate benefits as well, but tended to minimize potential harms.  Not only do physicians overestimate harm, they "underestimate how often most treatments have no effects on patients -- either harmful or beneficial"...

Todd Park: More can, should be done to capture unique EHR safety issues

Dan Bowman | Fierce Health IT | November 17, 2011

As Chief Technology Officer at the U.S. Department of Health & Human Services, it's Todd Park's job to be excited about innovation. And, as anyone who's seen him speak live can attest, he takes his job very seriously. Read More »

Top 10 eClinical Trends

The drug development industry is facing a revolution in the way clinical trials are being planned and conducted. It’s an industry that experiences rapid changes in technology adoption and business models, from new ways of capturing clinical data to new outsourcing strategies. This paper focuses on ten essential eClinical trends in order to help you understand which direction the biotech industry is prone to take in the next few years. As both the means, and the ultimate motivation of clinical development, patients are the most fundamental assets during the clinical trial process. We have summed up five trends that are destined to give them a more important role in the conduct of clinical studies: Boosting Patient Engagement, Integrated ePRO (electronic Patient Reported Outcomes) Systems, Mobile Clinical Studies, Personalized medicine, and Risk-based monitoring. Read More »

Top 10 Medical Research Trends To Watch In 2013

Margaret Anderson | Huffington Post | January 11, 2013

Congress has pushed the date of the "sequester" off another two months, delaying the prospect of automatic 8.2 percent cuts in the budgets of NIH, FDA, and other federal science programs. But a sequester (or other cuts) could still happen. [...] Read More »

Top Medicare Prescribers Rake In Speaking Fees From Drugmakers

Charles Ornstein, Tracy Weber, and Jennifer LaFleur | ProPublica | June 25, 2013

When the blood pressure drug Bystolic hit the market in 2008, it faced a crowded field of cheap generics. So its maker, Forest Laboratories, launched a promotional assault [...]. It flooded the offices of health professionals with drug reps, and it hired doctors to persuade their peers to choose Bystolic — even though the drug hadn't proved more effective than competitors. Read More »

Trial Designed With Crowd Input Gets FDA Signoff

Marc Iskowitz | MM&M | December 28, 2012

What's been called the first clinical study protocol developed using crowdsourcing methods received the FDA's imprimatur earlier this month. The agency approved Transparency Life Sciences' IND for a clinical trial designed to test a generic blood-pressure medication, ACE inhibitor lisinopril, in patients with relapsing remitting multiple sclerosis. Read More »

Trove Of Medical Devices Found To Have Password Problems

John Fontana | ZDNet | June 17, 2013

Surgical devices, ventilators, defibrillators, and monitors are among the equipment at risk. Read More »

U.S. Department Of Veteran Affairs Awards $28.8 Million TeleHealth Contract To AMC Health

Press Release | AMC Health | September 4, 2013

AMC Health, a leading provider of telehealth solutions, announced today that the U.S. Department of Veteran Affairs (VA) has awarded the company a five-year contract worth up to $28.8 million to provide telehealth solutions and services... Read More »

UnitedHealth Recalls Digital Health Record Software

Jordan Robertson | Bloomberg | September 10, 2013

UnitedHealth Group Inc. (UNH) has recalled software used in hospital emergency departments in more than 20 states because of an error that caused doctor’s notes about patient prescriptions to drop out of their files. Read More »

University of Chicago Awarded $20 Million To Host COVID-19 Medical Imaging Center

Press Release | University of Chicago | August 7, 2020

A new center hosted at the University of Chicago-co-led by the largest medical imaging professional organizations in the country-will help tackle the ongoing COVID-19 pandemic by curating a massive database of medical images to help better understand and treat the disease. Led by Prof. Maryellen Giger of UChicago Medicine, the Medical Imaging and Data Resource Center (MIDRC) will create an open-source database with medical images from thousands of COVID-19 patients. The center will be funded by a two-year, $20 million contract from the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health (NIH).

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