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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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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