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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Showing posts with label gmp training. Show all posts
Showing posts with label gmp training. Show all posts
Wednesday, December 17, 2014
Monday, July 21, 2014
Safety Alerts & Advisories > FDA Consumer Advice on Powdered Pure Caffeine
"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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Wednesday, July 16, 2014
GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters
Updated August 4, 2024
The original link broke.
You might also like:
--- the original post follows below ---
"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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Friday, June 27, 2014
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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Thursday, June 26, 2014
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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Wednesday, June 25, 2014
Electrical Current To Heal Cavities - Business Insider
You might also be interested in:
Goodbye to dental fillings? ‘No-drill’ techniques can treat tooth decay just as well, study finds
= = = original post follows below = = =
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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Friday, June 6, 2014
This Graphic of Counterfeit, Poison-Laced Pills Is Horrifying | TIME
Read the full article: This Graphic of Counterfeit, Poison-Laced Pills Is Horrifying | TIME:
"Rat poison, wall paint, antifreeze, paint thinner and a few other ingredients that have slipped into the $75 billion a year market for counterfeit pills
Today the world celebrates Anti-Counterfeiting Day, and by world, we mean a little-known coalition of regulators and lawyers celebrating their quiet battle against counterfeit drug makers."
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Friday, May 23, 2014
Eating Outdoors, Handling Food Safely - from the FDA
"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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More from the FDA:
- 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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Thursday, May 22, 2014
FDA > Press Announcements > FDA targets illegal online pharmacies in globally coordinated action
 |
| Ritalin (Photo credit: Wikipedia) |
"The FDA and the CBP inspected packages at the mail facilities in Los Angeles, New York and Chicago, and detained or seized 583 packages. Preliminary findings show that certain drug products from abroad, such as insulin, estrogen, bimatoprost, human chorionic gonadotropin, tramadol, tadalafil and sildenafil citrate were on their way to U.S. consumers. The FDA also notified Internet service providers, domain name registrars and related organizations that 1,975 websites were selling products in violation of U.S. law."
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Wednesday, May 21, 2014
Plane seat back pockets germier than toilet handles - Daily Dose
Updated April 17, 2021
The original link broke.
You can still read the article here:
--- the original post follows below ---
"The seat back pocket on a plane may be germier than the toilet handle, according to a new study, and certain bacteria may linger there for more than a week."
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Thursday, May 15, 2014
FDA - Consumer Updates > Temporary Tattoos May Put You at Risk
"However, "just because a tattoo is temporary it doesn't mean that it is risk free," says Linda Katz, M.D., M.P.H., director of FDA's Office of Cosmetics and Colors. Some consumers report reactions that may be severe and long outlast the temporary tattoos themselves."
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More from the FDA:
- Tattoos & Permanent Makeup
- Cosmetics
- Inked and Regretful: Removing Tattoos
- Think Before You Ink: Are Tattoos Safe?
- Tattoo Inks Pose Health Risks
- Five Tips for a Safer Spring Break
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Monday, May 12, 2014
National Women's Health Week - Health Topics on FDA.gov
Women's Health Topics - FDA.gov:
"Take Time to Care about Your Health. Women often spend so much time helping others that they don't take time for themselves. It's OK to take time to focus on good health."
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More from the FDA:
Watch a video or read a fact sheet to learn helpful tips on health issues like:
- Birth Control
- Breast Implants
- Diabetes
- Heart Health
- Mammograms
- Menopause
- Pregnancy
- Safe Medication Use
- Other Topics like cosmetics, nutrition, and HPV
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Wednesday, May 7, 2014
FDA: Foreign medtech firms receive excess manufacturing violations | MassDevice
"FDA inspectors have stepped up their surveillance of foreign medical device manufacturers, finding that they make up a disproportionate number of process and quality violations that result in formal warning letters.
Foreign firms accounted for about 10% of inspections conducted in 2012 but received 40% of the FDA warning letters. China alone was responsible for 12% of all the quality systems warning letters issued that year."
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You might also be interested in:
21 CFR 820 Essential Elements - A QSR Training Course
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Tuesday, May 6, 2014
A cup of coffee a day may keep retinal damage away | Cornell Chronicle
 |
| English: A photo of a cup of coffee. Esperanto: Taso de kafo. Français : Photo d'une tasse de caffé Español: Taza de café (Photo credit: Wikipedia) |
"Coffee drinkers, rejoice! Aside from java’s energy jolt, food scientists say you may reap another health benefit from a daily cup of joe: prevention of deteriorating eyesight and possible blindness from retinal degeneration due to glaucoma, aging and diabetes."
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FDA > Information for Consumers (Drugs) > Use of Aspirin for Primary Prevention of Heart Attack and Stroke
Updated August 8, 2024
The original link broke.
You can still read about the same topic here:
--- the original post follows below ---
"Cardiovascular disease, including heart disease and stroke, affects tens of millions of people in the United States. Consumers and patients who do not suffer from cardiovascular disease sometimes consider taking aspirin to reduce the possibility of having a heart attack or stroke. Reducing the possibility of having a first heart attack or stroke is called primary prevention. The FDA has reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain, in situations where the benefit of aspirin for primary prevention has not been established."
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Monday, May 5, 2014
FDA Releases FSMA Strategy Document as a 'Springboard for Discussion' | Food Safety News
"The document is meant “to guide the next phase of FSMA implementation by outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change.”
It includes plans for internal changes as well as changes to guides for implementing rules regarding food and feed facilities, produce safety and the new import system."
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Read the FDA's strategy document:
Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA) - Protecting Public Health by Strategic Implementation of Prevention-Oriented Food Safety Standards
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Some students don't see ADHD drug use as cheating - USA Today
"Nearly one in five students at an Ivy League university have misused ADHD drugs to improve their school performance, according to a new poll being presented Saturday at the Pediatric Academic Societies' annual meeting in Vancouver, Canada. The lead researcher, Andrew Adesman, declined to name the college he surveyed, saying that he's confident that the rate is virtually the same at every other school."
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Wednesday, April 30, 2014
One third of Americans mixing supplements with meds: study | Reuters
"“Multivitamins are commonly assumed to be safe, but our analysis suggests multivitamins, which may include multivitamin ‘plus’ combination products, can also contain botanical and herbal ingredients that have the potential to interact with prescription medications,” Harris Lieberman told Reuters Health in an email."
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Tuesday, April 29, 2014
CDC - NIIW home page - National Infant Immunization Week - Vaccines
"National Infant Immunization Week (NIIW), set for April 26 – May 3, 2014, is an annual observance to highlight the importance of protecting infants from vaccine-preventable diseases and celebrate the achievements of immunization programs and their partners in promoting healthy communities."
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More about vaccines, from the FDA:
- Vaccines for Children – A Guide for Parents and Caregivers
- Benefits and Risks
- Types of Routinely Administered Vaccines for Children
- Steps to Take When Your Child is Vaccinated
- Routinely Administered Vaccines for Children
- Parents and Caregivers are Asking
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Monday, April 28, 2014
FDA: For Women > Dietary Supplements: Tips for Women
For Women > Dietary Supplements: Tips for Women - FDA:
"Dietary supplements are products that people add to their diets. They include vitamins, minerals, herbs, and amino acids. They can be pills, liquids, powders or energy bars.
Although dietary supplements can help support good health, they may also cause side effects and health problems. It is important to think about the health benefits and risks before taking any product.
Tips for Women
Anyone can have problems with dietary supplements. Some women need to take special steps to stay safe."
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"Dietary supplements are products that people add to their diets. They include vitamins, minerals, herbs, and amino acids. They can be pills, liquids, powders or energy bars.
Although dietary supplements can help support good health, they may also cause side effects and health problems. It is important to think about the health benefits and risks before taking any product.
Tips for Women
Anyone can have problems with dietary supplements. Some women need to take special steps to stay safe."
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