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

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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Wednesday, June 25, 2014

Dietary Supplement Manufacturer Audit Preparation - NPI

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:
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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Monday, June 23, 2014

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

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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Sunday, June 22, 2014

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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Tuesday, June 17, 2014

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

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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Thursday, June 12, 2014

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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Friday, June 6, 2014

This Graphic of Counterfeit, Poison-Laced Pills Is Horrifying | TIME

How did I miss World Anti-Counterfeiting Day (June 5)?

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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