Wednesday, December 31, 2014

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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Tuesday, December 30, 2014

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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Monday, December 22, 2014

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

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

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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Friday, December 19, 2014

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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Thursday, December 18, 2014

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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Wednesday, December 17, 2014

Belly Fat Tied to Sudden Cardiac Death - NYTimes.com

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

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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Tuesday, December 9, 2014

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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Wednesday, November 19, 2014

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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Tuesday, November 18, 2014

FDA - Consumer Updates > Food Safety Tips for Healthy Holidays

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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Additional links:

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Monday, November 17, 2014

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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Friday, November 14, 2014

Best Practices for Handling FDA Inspections - Pharmaceutical Compliance Monitor

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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Thursday, November 13, 2014

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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Tuesday, November 11, 2014

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

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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Wednesday, November 5, 2014

GMP News: Statistical Analysis of FDA's Inspection Findings

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

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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Friday, October 3, 2014

2014 Ebola Outbreak in West Africa - FDA.gov

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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