Food and Drug Administration (FDA)

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Amazon hires openFDA trailblazer Kass-Hout for healthcare project: report

Nick Paul Taylor | FierceBiotech | March 19, 2018

Amazon has hired former FDA chief health informatics officer Taha Kass-Hout, M.D., CNBC reports. Kass-Hout led the groundbreaking openFDA initiative and rehabilitated the reputation of the FDA’s IT department during his three years at the agency. Details of what Kass-Hout will do at Amazon are scarce....during his time at the FDA, Kass-Hout lead the precisionFDA program that established a collaborative, open approach to genomic testing references. Across the initiatives, Kass-Hout deployed approaches that were established in tech circles but alien to the FDA prior to his arrival. Open-source projects that embraced the cloud, shared their code on GitHub and invited programmers to hackathons became commonplace.

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An Ultra-Simple Tourniquet That’s Saving Soldiers’ Lives

Joseph Flaherty | Wired | June 23, 2014

...[T]he SAM Junctional Tourniquet, which weighs just over a pound and can be deployed in under 25 seconds, a critical benefit where medics only have about 90 seconds to save their patient’s life. Its simple, belt-like appearance belies important innovations...

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Animal Antibiotics: FDA Rules Criticized As Weak As McDonald's

Ben Elgin and Andrew Martin | Bloomberg Businessweek | January 2, 2014

A delegation of public-health advocates filed into the suburban Chicago headquarters of McDonald’s (MCD) last January to deliver a tough message: A decade after the fast-food giant’s groundbreaking promise to reduce medically important antibiotics fed to the animals it buys, the policy had glaring loopholes and was having a questionable impact. Read More »

Animal Health Institute Statement On FDA Final Guidance 213

Press Release | Animal Health Institute (AHI) | December 11, 2013

The Animal Health Institute (AHI) issued the following statement in response to the Food and Drug Administration’s publication of the final Guidance 213 and proposed VFD rule implementing the policy of extending veterinary oversight and eliminating  the subtherapeutic use of medical important antibiotics in animal agriculture. Read More »

Another Scope, Similar Infection Worries

Chad Terhune and Melody Peterson | Los Angeles Times | December 20, 2015

Long before the recent superbug outbreaks, Olympus Corp. drew national attention for a faulty device tied to patient infections. In 2001, the Japanese company recalled thousands of bronchoscopes from U.S. hospitals after reports of contamination and patient infections. The episode — and the company's response to it — mirrors its current troubles with gastrointestinal scopes. Bacteria were trapped unexpectedly inside a loose biopsy port on the bronchoscope, and potentially dangerous bugs could be passed to the next patient. More recently, a similar pattern emerged with duodenoscopes harboring life-threatening superbugs even though hospitals followed Olympus' cleaning instructions, federal regulators said...

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Antibiotic Resistance: How Industrial Agriculture Lies With Statistics

Robert Lawrence | Huffington Post | January 23, 2014

...The website of the Alliance, a coalition of corporations and trade associations that make up a who's who of industrial agriculture, says the organization wants "to engage in dialogue with consumers who have questions about how today's food is grown and raised." It appears, however, that the organization is more concerned with countering increasing awareness of the public health and environmental harms associated with industrialized agriculture...

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Antibiotic Use In Chickens: Responsible For Hundreds Of Human Deaths?

Maryn McKenna | Wired | August 9, 2013

In the long back and forth between science and agriculture over the source of antibiotic resistance in humans — Due to antibiotic overuse on farms, or in human medicine? — one question has been stubbornly hard to answer. If antibiotic-resistant bacteria do arise on farms, do they leave the farm and circulate in the wider world? And if they do, how much damage do they do? Read More »

Antibiotic Use On The Farm: Are We Flying Blind?

Dan Charles | NPR | August 29, 2013

There's a heated debate over the use of antibiotics in farm animals. Critics say farmers overuse these drugs; farmers say they don't. Read More »

Antibiotic-Resistant 'Superbugs' Creep Into Nation's Food Supply

Mark Koba | CNBC | April 18, 2013

Antibiotic-resistant bacteria—often called "superbugs"—are entering the nation's food system and endangering consumers at an alarming rate, according to researchers who analyzed data from the federal government. Read More »

Antibiotics And The Meat We Eat

David A. Kessler | New York Times | March 27, 2013

SCIENTISTS at the Food and Drug Administration systematically monitor the meat and poultry sold in supermarkets around the country for the presence of disease-causing bacteria that are resistant to antibiotics. These food products are bellwethers that tell us how bad the crisis of antibiotic resistance is getting. And they’re telling us it’s getting worse. Read More »

Apple Watch Leaves Patients Connected with Nowhere To Go

The highly anticipated unveiling of the Apple Watch Series 4 caused a news and social media sensation. Apple coined the iconic timepiece as the "guardian of your health", with health tracking functionalities such as the ability to detect atrial fibrillation (AFib) by a self-performed electrocardiogram (ECG). But from patients' and carepartners' perspectives, there is a long road to a universally accessible, seamlessly implemented, mass-adoption, and meaningful use for this wearable technology...Unfortunately, the vast majority of concerns in the public domain haven't emphasized the risks to health due to poor implementation, integration, and adoption strategies of digital tools and wearables.

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Apple-powered bionic pancreas one step closer

Philip Elmer-DeWitt | Fortune | June 16, 2014

A paper in the prestigious New England Journal of Medicine highlights both the potential benefits of Apple’s newly unveiled HealthKit platform and how far off those benefits might still be. Read More »

Approval Of A Coronavirus Vaccine Would Be Just The Beginning - Huge Production Challenges Could Cause Long Delays

The race for a SARS-CoV-2 vaccine is well underway. It's tempting to assume that once the first vaccine is approved for human use, all the problems of this pandemic will be immediately solved. Unfortunately, that is not exactly the case. Developing a new vaccine is only the first part of the complex journey that's supposed to end with a return to some sort of normal life. Producing hundreds of millions of vaccines for the U.S. - and billions for the world as a whole - will be no small feat. There are many technical and economic challenges that will need to be overcome somehow to produce millions of vaccines as fast as possible.

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Artificial intelligence in medicine: Is the genie out of the bottle?

It is probably a given that artificial intelligence (AI) will become an integral part of healthcare delivery and of our public health infrastructure. What is not a given is that we will easily reach that point, and maintain progress in a way that maximizes its effectiveness in achieving the goals we have come to expect of it – efficient and improved healthcare and public health systems. In other words, making the health of people better in a cost-effective way. Responsible commentators have already begun to question the value of AI in medicine.

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Artificial Pancreas Shows Promise in Diabetes Test

Nicholas Bakalar | New York Times | June 15, 2014

A portable artificial pancreas built with a modified iPhone successfully regulated blood sugar levels in a trial with people who have Type 1 diabetes, researchers reported Sunday.

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