Flu season shaping up to be brutal - CNBC

Read the full article: Flu season shaping up to be brutal - CNBC:

"We're in the midst of what looks like a "very early and pretty aggressive flu season," according to Michael Smith, a doctor and chief medical editor for WebMD.

Flu season occurs during the colder months of the year and typically peaks between December and February, according to the Centers for Disease Control and Prevention."

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Traffic Stops Persuade People To Avoid Drinking And Driving : Shots - Health News : NPR

Read the full article: Traffic Stops Persuade People To Avoid Drinking And Driving : Shots - Health News : NPR:

"The study was published online in Alcoholism: Clinical and Experimental Research.

The same went for arrests for driving under the influence. The more DUI arrests, the fewer drunken drivers out on the roads.

In large part, Fell says, that's because word spreads quickly. When people know DUI laws are strictly enforced, "They think twice about drinking and driving." And when people see someone pulled to the side of the road by a cop, he adds, they'll likely consider their own speed and sobriety."

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FDA > Buy, Store & Serve Safe Food > Safe Food Handling: What You Need to Know

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Read the full article: Buy, Store & Serve Safe Food > Safe Food Handling: What You Need to Know - FDA.gov:

"The Federal government estimates that there are about 48 million cases of foodborne illness annually – the equivalent of sickening 1 in 6 Americans each year. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths.

Since foodborne illness can be serious — or even fatal — it is important for you to know and practice safe food handling behaviors to help reduce your risk of accidentally getting sick from contaminated food."

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Happy Holidays: FDA Moves to Ban Cake, Donut 'Sprinkles' - Breitbart

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Read the full article: Happy Holidays: FDA Moves to Ban Cake, Donut 'Sprinkles' - Breitbart:

"Although the amount of trans fats Americans consume has declined significantly in recent years, the FDA’s quest to completely eliminate a particular type of trans fat threatens to eliminate the noble “sprinkle,” used to decorate holiday treats and donuts. Even a small amount of joy is suspect in the FDA’s brave, new, food-monitored world."

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Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor

Read the full article: Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor:

". . . it might come as a surprise that most data breaches occurred within the medical/healthcare category. According to the Identity Theft Resource Center, 600+ breaches have taken place through October 2014—up nearly 26 percent from 2013. Healthcare providers and organizations account for approximately 42 percent of all breaches with 7.4 million personal records exposed this year alone.

Looking at these numbers it’s hard to argue against the vulnerability of any organization, regardless of their stature. Today, with advanced tools at hackers’ disposal, it’s truly not a matter of ‘if’ but ‘when’ a data breach will materialize."

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Questionable Remedies for Eye Disease - NYTimes.com

RE: slowing the progression of macular degeneration and reducing the risk of vision loss

Read the full article: Questionable Remedies for Eye Disease - NYTimes.com:

"Some contained the right ingredients but not the right doses. Some added other stuff (selenium, B vitamins, grapeseed extract) that hasn’t been shown to slow macular degeneration and might actually reduce the effectiveness of the ingredients that do work. Of the 11 supplements that market research shows were top-sellers, only four duplicated the AREDS formula.

 Moreover, most manufacturers didn’t bother to point out that the AREDS results don’t pertain to everyone with macular degeneration, and that therefore some consumers won’t benefit from these products."

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Belly Fat Tied to Sudden Cardiac Death - NYTimes.com

Updated February 10, 2022

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Big Belly, Bigger Heart Risk - NDTV Food

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Read the full article: Belly Fat Tied to Sudden Cardiac Death - NYTimes.com:

"As the researchers expected, those who died suddenly had higher rates of other cardiac risk factors, including obesity, hypertension, high cholesterol and more. But independent of these factors, those with the highest waist-to-hip ratio had more than double the risk of sudden cardiac death compared with those in the normal range. The increased risk was apparent only in nonsmokers."

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FDA Approves Blood Test That Gauges Heart Attack Risk – WebMD

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Read the full article: FDA Approves Blood Test That Gauges Heart Attack Risk – WebMD:

"The U.S. Food and Drug Administration on Monday approved a new blood test that can help determine a person's future odds for heart attack and other heart troubles.

The test is designed for people with no history of heart disease, and it appears to be especially useful for women, and black women in particular, the agency said."

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Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT

Read the full article: Eager-to-please Indian manufacturers creating GMP chaos says expert - iPT:

"The problem is “cultural,” said Shah, originally from India and now head of UK-based Sigma, speaking afterwards to in-Pharmatechnologist.com.

“The classic thing in India is these guys will never say no. You will say to them, ‘I need this done,’ and they’ll say ‘Of course.’”

The result is delays and frustration from buyers, he said."

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The Top 15 Medical Device Deficiencies Cited by FDA in 2014 | RAPS

Read the full article, and view graphics: The Top 15 Medical Device Deficiencies Cited by FDA in 2014 | RAPS:

"The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies.

Total 483s Issued Declines for First Time in Six Years"

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View FDA Inspection Data:
FY 2014 Inspectional Observation Summaries - Number of 483s Issued from the System (Inspections ending between 10/1/2013 12:00:00 AM and 9/30/2014 12:00:00 AM)

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CRN FDA GMP Warning Letter Database - For Dietary Supplements - Free

Read the full press release: CRN FDA GMP Warning Letter Database Document:

"The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today announced a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products tainted with illegal ingredients."

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Access the CRN FDA Warning Letters Database for Dietary Supplements

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FDA - Consumer Updates > Food Safety Tips for Healthy Holidays

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Read the full article: Consumer Updates > Food Safety Tips for Healthy Holidays - FDA.gov:

"Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home.

"The good news is that practicing four basic food safety measures can help prevent foodborne illness," says Marjorie Davidson, a consumer educator at FDA."

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Great American Smokeout - Thurs Nov 20 | American Cancer Society

Learn more:  Great American Smokeout | American Cancer Society:

"The American Cancer Society marks the Great American Smokeout on the third Thursday of November each year by encouraging smokers to use the date to make a plan to quit, or to plan in advance and quit smoking that day. By quitting — even for one day — smokers will be taking an important step towards a healthier life – one that can lead to reducing cancer risk."

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Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor

• Trusted FDA GMP online training courses taught by SkillsPlus International Inc.

Updated July 30, 2021

Sadly, the original link broke.

---  the original post follows below  ---

Read the full article: Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor:

"Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

Based on 15 years of experience and eight successful FDA inspections, here are some best practices to prepare for a successful FDA Inspection."

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Hospital Workers Wash Hands Less at End of Shift, Study Finds - HealthDay

Read the full article: Hospital Workers Wash Hands Less at End of Shift, Study Finds - HealthDay:

"Health workers in hospitals wash their hands less often as they near the end of their shift, a new study has found.

And this lapse -- likely due to mental fatigue -- could contribute to hundreds of thousands of patient infections a year in the United States, the researchers noted."

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Trouble Swallowing Pills? Here’s 2 Ways to do it Right - American News

Updated May 8, 2023

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Trouble Swallowing Pills? Try The 'Pop Bottle' Or The 'Lean Forward' - NPR.org

---  the original post follows below  ---

Read the full article for more details: Trouble Swallowing Pills? Here’s 2 Ways to do it Right - American News:

"“In conclusion, this study showed for the first time that two targeted techniques to facilitate tablet and capsule intake were remarkably effective and easy to adopt in the general population including patients with swallowing difficulties, and should therefore be generally recommended,” the study authors write."

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Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill - WSJ - WSJ

Read the full article: Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill - WSJ - WSJ:

"Doctors are testing seniors for drugs such as heroin, cocaine and “angel dust” at soaring rates, and Medicare is paying the bill.

It is a roundabout result of the war on pain-pill addiction.

Medical guidelines encourage doctors who treat pain to test their patients, to make sure they are neither abusing pills nor failing to take them, possibly to sell them.

Now, some pain doctors are making more from testing than from treating."

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GMP News: Statistical Analysis of FDA's Inspection Findings

• FDA CGMP Online Training - trusted GMP training courses provided by SkillsPlus International Inc.

Follow this link to view the graph: GMP News: Statistical Analysis of FDA's Inspection Findings:

"The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.

Another interesting summary is the webpage with FAQs relating to the 483 Form.

The following graph shows an analysis of the 483 identified during fiscal year 2013." . . .

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FDA: Consumer Updates > Mixing Medications and Dietary Supplements Can Endanger Your Health

• Trusted FDA GMP online training programs and courses by SkillsPlus International Inc.

Read the full article: FDA - Consumer Updates > Mixing Medications and Dietary Supplements Can Endanger Your Health:

"What is FDA’s Role?

Although FDA has oversight of the dietary supplement industry, it is the supplement manufacturers and distributors that are responsible for making sure their products are safe before they’re marketed. Manufacturers are required to produce dietary supplements that meet minimum quality standards, do not contain contaminants or impurities, and are accurately labeled.

FDA does not review supplements for effectiveness (as it does for prescription and OTC medications) before they enter the market. If the dietary supplement contains a new dietary ingredient, the manufacturer must submit for FDA’s review data on that ingredient’s safety—but not its effectiveness.

FDA takes enforcement actions against manufacturers if their products are found to be unsafe, adulterated and/or misbranded (for example, if their labeling is false or misleading) or if products marketed as dietary supplements are making claims to diagnose, mitigate, treat, cure, or prevent a disease."

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2014 Ebola Outbreak in West Africa - FDA.gov

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Updated February 24, 2021

Links in the original post broke.

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Ebola Preparedness and Response Updates from FDA - FDA.gov

- - -  the original post follows below  - - -

Read the full FDA article: Medical Countermeasures Initiative > 2014 Ebola Outbreak in West Africa - FDA.gov:

"Fast Facts 

• Ebola is the cause of a viral hemorrhagic fever disease.
• Currently, there are no FDA-approved vaccines or drugs to prevent or treat Ebola.
• Ebola does not pose a significant risk to the U.S. public.

Treatment:
CDC recommends supportive therapy for patients as the primary treatment for Ebola. This includes balancing the patient’s fluids and electrolytes, maintaining their oxygen status and blood pressure and treating them for any complicating infections."

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What You Should Know for the 2014-2015 Influenza Season | Seasonal Influenza (Flu) | CDC

Read the full fact page: What You Should Know for the 2014-2015 Influenza Season | Seasonal Influenza (Flu) | CDC:

"People should begin getting vaccinated soon after flu vaccine becomes available, ideally by October, to ensure that as many people as possible are protected before flu season begins."

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Five Steps That Men Can Take to Avert a Heart Attack - NBC News.com

Read the full article: Five Steps That Men Can Take to Avert a Heart Attack - NBC News.com:

"Men who take just five healthy steps can reduce their odds of a heart attack by four-fifths, but just 1 percent of men do so on their own, according to new research published Monday. The steps are nothing secret: They are not smoking, drinking moderately, exercising daily, eating a healthy diet and keeping the belly in check."

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FDA to Middle-Aged Men: You Probably Don’t Need Testosterone Therapy - MensJournal.com

Read the full article: FDA to Middle-Aged Men: You Probably Don’t Need Testosterone Therapy - MensJournal.com:

" A recent study found that testosterone therapies doubled the heart attack risk for men over age 65 and for younger men with a history of heart disease after only three months of use. And in June the FDA began requiring drug manufacturers to include a warning label on product packaging, stating that these treatments may cause blood clots.

Schwartz says they may also increase PSA levels, an indicator of prostate cancer risk, although they haven’t been proven to increase the risk. “Given these potential harms and the fact that these are unproven therapies for men with low T of aging,” she says, “what’s going on right now is a huge uncontrolled experiment.”"

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Hallucinogen in 'magic mushrooms' helps longtime smokers quit in Hopkins trial | Hub

Read the full article: Hallucinogen in 'magic mushrooms' helps longtime smokers quit in Hopkins trial | Hub:

"Johns Hopkins researchers report that a small number of longtime smokers who had failed many attempts to drop the habit did so after a carefully controlled and monitored use of psilocybin—the active hallucinogenic agent in so-called "magic mushrooms"—in the context of a cognitive behavioral therapy treatment program.

The abstinence rate for study participants was 80 percent after six months, much higher than typical success rates in smoking cessation trials, says Matthew W. Johnson, an associate professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, and the corresponding author on the study."

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Health Canada: We do not enforce the law when Canadians poison Americans - Searching for Safety

Read the full article: Health Canada: We do not enforce the law when Canadians poison Americans - Searching for Safety:

"Simply put, Health Canada admits that it does not intend to enforce the law on Canadian internet pharmacies that sell to foreigners.  We suspected this was the excuse, but now it’s official. As Health Canada’s response says:

Health Canada prioritizes its work according to the risk to health that the incident may pose to Canadians. Incidents that present a potentially higher risk to health will be actioned first. Incidents of low or nominal risk will be assessed and entered into our tracking system for possible future compliance action as deemed appropriate."

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New Influenza drug Peramivir by BioCryst Pharma Treats Flu in One Dose | Capital OTC

Updated July 29, 2021

The original link broke.

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FDA approves BioCryst's intravenous flu drug - Reuters

---  the original post follows below  ---

Read the full article: New Influenza drug Peramivir by BioCryst Pharma Treats Flu in One Dose | Capital OTC:

"According to latest studies, a single dose of new antiviral drug Peramivir is safe and effective in treating influenza in adults when it is administered within 48 hours of the appearance of the symptoms of Flu."

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More deadly pathogens, toxins found improperly stored in NIH and FDA labs - The Washington Post

Read the full article: More deadly pathogens, toxins found improperly stored in NIH and FDA labs - The Washington Post:

"Officials at the National Institutes of Health said Friday a search on their sprawling Bethesda campus had turned up five different misplaced biological materials in recent weeks. All of them are considered so dangerous — they are known as “select agents” — that the government requires them to be stored in specially secured facilities. But in these cases, the vials were in regular labs, often part of collections of samples that date back decades.

Simultaneously, the Food and Drug Administration said it had found vials of staphylococcal enterotoxin, a frequent cause of food-borne illness, at a lab within the agency’s Center for Food Safety and Applied Nutrition that was not registered to handle it."

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Biotechnology to the Rescue - US News

Read the full article: Biotechnology to the Rescue - US News:

"The life sciences industry is in the middle of a historic boom, churning out new medical weapons at an unprecedented pace. In 2012, the Food and Drug Administration approved 39 “new molecular entities,” completely novel drugs to treat everything from cancer to tuberculosis to HIV. It topped that off by adding 27 more last year, and there are now more than 4,000 investigational medicines in the pipeline.

Medical device-makers are also in high gear; the 33 products approved in 2013 include replacement hips, new cardiac stents and prosthetic spinal discs. Here’s a sampling of the most innovative developments transforming medical practice and offering patients new hope:"

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Company tests a way to deliver vaccines by a skin 'patch' - Boston Business Journal

Read the full article: Company tests a way to deliver vaccines by a skin 'patch' - Boston Business Journal:

"An Australian biotech startup with an office in Cambridge's Kendall Square has developed a way to deliver vaccines to patients without using a syringe or nasal mist. Vaxxas Inc. has developed the Nanopatch, which consists of thousands of vaccine-coated microprojections that penetrate the outer layers of a patient’s skin.

The nano-level sized microprojections are coated with vaccine and then released directly to key immune cells found just below the skin’s surface, according to Vaxxas CEO David Hoey."

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UAVs Give New Meaning To Drug Delivery - Med Device Online

Read the full article: UAVs Give New Meaning To Drug Delivery: - Med Device Online

"A Palo Alto- and London-based startup company is developing unmanned aerial vehicle (UAV) technology with a new twist. Instead of performing remote surveillance or delivering explosives with surgical accuracy, they distribute payloads of medical supplies.

Reaching remote areas in developing countries can be difficult, especially in times of disaster. Roads may not be accessible, or a region may be quarantined due to an infectious disease "

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What? No More Annual Pelvic Exams? - Medscape

Read the full article: What? No More Annual Pelvic Exams? - Medscape:

"No More Routine Pelvic Exams...Really?

I am a female general internist. I provide well-woman screening -- including "the" pelvic exam -- for the vast majority of my patients. That's why new clinical practice guidelines from the American College of Physicians (ACP),[1] based on a comprehensive systematic review of 68 years' worth of English-language evidence, really caught my eye. I read ACP's strong recommendation: "ACP recommends against performing screening pelvic examination in asymptomatic, nonpregnant, adult women." My first thought was, "Really?""

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Food additives on the rise as FDA scrutiny wanes - The Washington Post

Read the full article: Food additives on the rise as FDA scrutiny wanes - The Washington Post:

"The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

And in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show.

“We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food."

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India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ

Updated October 7, 2023

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India’s CDSCO outlines procedures for state inspections of manufacturers

---  the original post follows below  ---

Read the full article: India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ:

"Last year, the FDA conducted 111 inspections in India, up from 98 in 2011 and 59 in 2009, and has issued warning letters to several Indian drug makers. Significantly, the FDA also issued 21 so-called import alerts that allow the FDA to ban products from entering the U.S.

One widely known example is Ranbaxy Laboratories [500359.BY +1.16%], which is prevented from sending products from four of its plants in India and is also operating under a consent decree that requires improvements before the ban can be lifted. Sun Pharmaceuticals [524715.BY +1.46%] recently agreed to buy Ranbaxy for $3.2 billion"

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Quality of Dietary Supplements - QM USP

Updated Mar 24, 2023

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Dietary Supplements - USP Quality Matters

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Read the full article: Quality of Dietary Supplements - QM (Quality Matters) USP:

"In the United States, current Good Manufacturing Practices (cGMPs) for dietary supplements are mandated by law, and the FDA has the authority to oversee dietary supplement companies for compliance with those GMPs. This provision of the law acts to safeguard consumers of some quality issues, helping to keep dietary supplements from becoming adulterated.

However, most quality specifications for dietary supplements in the United States are set by manufacturers with no premarketing oversight and few uniform requirements. For that reason, the quality of dietary supplements may vary significantly from one manufacturer to another.

Moreover, dietary supplements and their ingredients may be manufactured in countries with weaker regulatory systems making it even more difficult to control the quality of dietary supplements imported into our domestic market."

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Smart pill firm Proteus raises $172 million | Reuters

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Read the full article: Smart pill firm Proteus raises $172 million | Reuters:

"A U.S. biotech company pioneering tablets containing embedded microchips that can tell if patients have taken their medication has raised a further $172 million, showing investor interest in its ingestible and wearable technology.

Privately held Proteus Digital Health, which is working with drugmakers including Novartis and Otsuka, said on Tuesday the funding was one of the biggest U.S. private financings this year and the largest in the digital health sector.

Proteus already has European and U.S. approval for its "smart pill" technology system, in which a tiny sensor is embedded in a tablet and linked to a patch worn on the patient's abdomen."

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Safety Alerts & Advisories > FDA Consumer Advice on Powdered Pure Caffeine

Read the full alert: FDA Consumer Advice on Powdered Pure Caffeine - FDA.gov:

"Key Message

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.

The FDA is aware of at least one death of a teenager who used these products.

These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.

Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.

Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages."

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GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Updated August 4, 2024

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Warning Letters - FDA.gov

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Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 

that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

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Spoonfuls can lead to medicine errors, study finds - US News

Read the full article: Spoonfuls can lead to medicine errors, study finds - US News:

"Parents who used spoonfuls "were 50% more likely to give their children incorrect doses than those who measured in more precise milliliter units," said Dr. Alan Mendelsohn, a co-author and associate professor at New York University's medical school.

Incorrect doses included giving too much and too little, which can both be dangerous, he said. Underdosing may not adequately treat an illness and can lead to medication-resistant infections, while overdoses may cause illness or side effects that can be life-threatening. The study doesn't include information on any ill effects from dosing mistakes."

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Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov

Read the full article: Buy, Store & Serve Safe Food > Eating Outdoors, Handling Food Safely - FDA.gov:

"Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.

To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived."

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• Pack and Transport Food Safely
• Quick Tips for Picnic Site Prep
• Follow Safe Grilling Tips
• Serving Picnic Food: Keep it Cold/Hot

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FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice

Read the full article (and view video): FDA approves 1st exoskeleton to help paralyzed walk again | MassDevice:

"FDA regulators announced this evening that they approved for the U.S. market the 1st robotic exo-suit for helping patients with lower-body paralysis walk upright.

Called ReWalk , the motorized system is comprised of metal leg braces that strap around the legs and back, supplying movement to joints in the hips, knees and ankles. The system includes a watch-based remote that controls the suit's movements and patients rely on crutches to provide stability."

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Aspirin May Cut Pancreatic Cancer Risk - NYTimes.com

Read the full article: Aspirin May Cut Pancreatic Cancer Risk - NYTimes.com:

"A new study adds to the evidence that low-dose aspirin, known to reduce the risk for heart disease, may also reduce the risk for pancreatic cancer.

Pancreatic cancer has a 93 percent fatality rate, and the National Cancer Institute estimates there will be about 46,000 new cases and 40,000 deaths from the disease this year."

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Dietary Supplement Manufacturer Audit Preparation - NPI

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Read the full article: Dietary Supplement Manufacturer Audit Preparation - NPI:

"Common Mistakes Auditors Find

Recent GMP audits reveal companies failure to perform tasks in two main areas:

Quality Issues

• Perform required identity testing on incoming dietary ingredients raw materials
• Set appropriate specifications for raw materials, components and finished good product
• Perform finished good product testing confirming identity, strength and composition
• Lack of finished product release criteria (does finished batch conform to product spec?)
• Adopt written procedures (e.g., SOPs)
• Prepare and follow master manufacturing records (MMR) and/or batch production records (BPRs) for manufacture of dietary supplements (with formulation and batch size)
• Document corrective actions undertaken
• To conduct required material reviews and make disposition decisions

Facility Issues

• Physical plant design
• Sanitation requirements of the physical plant and associated grounds
• Issues with manufacturing equipment and utensils"

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Electrical Current To Heal Cavities - Business Insider

Updated Dec 8, 2015:
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Goodbye to dental fillings? ‘No-drill’ techniques can treat tooth decay just as well, study finds

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Read the full article: Electrical Current To Heal Cavities - Business Insider:

"Researchers at King's College London have developed a technique called Electrically Accelerated and Enhanced Remineralzation, in which a device they've dubbed a "healing hand piece" is placed over the site of a cavity. The tool emits a small electrical current that promotes the remineralization of the tooth, driving calcium, phosphate, and other substances back into the enamel, the scientists told the Washington Post (cavities happen when bacteria break down, or demineralize, the enamel with acid). The technique would take about as much time and cost about the same or less than a traditional filling, and publications describing the technique should be published "in coming months," they said."

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Marijuana Considered for Looser Restrictions by U.S. FDA - Bloomberg

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Read the full article: Marijuana Considered for Looser Restrictions by U.S. FDA - Bloomberg:

"U.S. regulators are studying whether restrictions on marijuana should be eased, a step toward decriminalizing the drug at the federal level.

The Food and Drug Administration is conducting an analysis at the Drug Enforcement Administration’s request on whether the U.S. should downgrade the classification of marijuana as a Schedule 1 drug, said Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA, at a congressional hearing."

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Medtronic got hacked, company reveals | MassDevice

Read the full article: Medtronic got hacked, company reveals | MassDevice:

"Medtronic reported in regulatory filings today that it and 2 other unnamed "large medical device manufacturers" were targeted by hackers appearing to originate from Asia. Those infiltrators didn't breach any patient data, Medtronic assured regulators.

Medtronic offered few other details regarding the hack, but the disclosure seems to fall in line with an reports earlier this year that Chinese hackers targeted systems at Medtronic, Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ)."

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FDA Prepping Long-Awaited Plan to Reduce Salt - ABC News

Updated June 29, 2023

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Sodium Reduction - FDA.gov

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Read the full article: FDA Prepping Long-Awaited Plan to Reduce Salt - ABC News:

"Food companies and restaurants could soon face government pressure to make their foods less salty — a long-awaited federal effort to try to prevent thousands of deaths each year from heart disease and stroke.

The Food and Drug Administration is preparing to issue voluntary guidelines asking the food industry to lower sodium levels, FDA Commissioner Margaret Hamburg told The Associated Press. Hamburg said in a recent interview that the sodium is "of huge interest and concern" and she hopes the guidelines will be issued "relatively soon."

"We believe we can make a big impact working with the industry to bring sodium levels down, because the current level of consumption really is higher than it should be for health," Hamburg said."

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Put Medicines Up and Away For Child Safety

The FDA emphasizes that it's National Safety Month.

View the website of: Up and Away:

"Any kind of medicine or vitamin can cause harm if taken in the wrong way, even medicine you can buy without a prescription. Walk around your house and find a storage place too high for a child to reach or see."

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FDA > Fish: What Pregnant Women and Parents Should Know

Read the full article: Metals > Fish: What Pregnant Women and Parents Should Know - FDA:

"Key Message:  Eat 8 to 12 ounces of a variety of fish* each week from choices that are lower in mercury. The nutritional value of fish is important during growth and development before birth, in early infancy for breastfed infants, and in childhood."

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Warning - What Is Secondary Drowning of Kids?

Updated February 9, 2017 (the original video disappeared):

I've never heard of "Secondary Drowning" until now.  Now that school is out for Summer, be on the lookout.


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