FDA To Share Nanotoxicology Information

According to this FDA Law Blog post, Nanotech Update: FDA Enters Into MOU With Air Force Research Laboratory to Facilitate Sharing of Nanotoxicology Information, "FDA’s National Center for Toxicological Research (“NCTR”) has entered into a Memorandum of Understanding (“MOU”) that provides for the sharing of nanotoxicology information with the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division (“AFRL”). "

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Hidden Health and Financial Liabilities of Nanotechnology
Should The FDA Oversee Nanotechnology Dietary Supplements?

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New Technique Might Help Diagnose Mesothelioma

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This Medical News Today article reports a new technique that might be helpful in diagnosing mesothelioma, New Technique Can Help Diagnose Mesothelioma.

A new technique may help clinicians diagnose patients presenting with a pleural effusion (accumulation of fluid in the pleural cavity) of unknown cause. One of the causes of pleural effusion is malignant pleural mesothelioma, a relatively rare cancer. Currently, the first-line test for mesothelioma in patients with a pleural effusion is pleural fluid cytology, but this test isn't very sensitive.

The research study results demonstrate that pleural fluid mesothelin levels were over six times greater in patients with mesothelioma than in patients with metastatic carcinomas, and ten times greater than in patients with benign effusions. This means serum mesothelin is a diagnostic biomarker for mesothelioma. Pleural fluid values are significantly higher than serum levels and may offer additional value over pleural fluid cytology for diagnosis of pleural malignancy. Additionally, pleural fluid mesothelin is a valuable adjunct to cytological examination in patients with an undiagnosed pleural effusion.

Read the research study abstract:
Clinical Impact and Reliability of Pleural Fluid Mesothelin in Undiagnosed Pleural Effusions

Previous Posts:
Hidden Health and Financial Liabilities of Nanotechnology
CDC Says Mesothelioma Deaths Increasing

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• Mesothelioma Resource Center Enters Twitter World (prweb.com)

FDA Announces Doubling Of Foreign Inspections

According to this FDA News article, FDA to Double Foreign GMP Inspections This Year, the FDA is going to double its inspections of facilities for good manufacturing practice (GMP) compliance this year.

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• U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. (fda.gov)

FDA Launches New Tobacco Products Center

The Food & Drug Administration (FDA) has launched its new FDA Center for Tobacco Products. The Center will oversee the implementation of the Family Smoking Prevention & Tobacco Control Act signed by President Obama in June 2009. The FDA's responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products and establishing and enforcing advertising and promotion restrictions.

I particularly like the following tools they make available:

• Calculator: How Much Does Smoking Cost You?
• Reasons to Quit
• Addiction Test
• How Does Smoking Affect Your Lifespan?

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• FDA Has New Power Over Tobacco (blisstree.com)

FDA Proposes Electronic Safety Reporting

The FDA states in their news release, FDA Proposes Mandatory Electronic Safety Reporting - New Rules will Help Strengthen Postmarket Safety Data Collection, that they've issued two proposed rules — one that applies to electronic medical device adverse event reporting, and one that applies to electronic drug and biologic product adverse experience reporting. The proposed rules would not change what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review, and archive.

Additional Information From the FDA:

• FDA’s Web site on Electronic Medical Device Reporting: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
• FDA’s Web site on the FDA eSubmitter: http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
• Fact Sheet: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm179586.htm

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• FDA Presents Ten Years Of Summary Statistics For Its Adverse Event Reporting System (AERS) (drug-injury.com)

Aspirin Fights Colon Cancer (video)

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I've been following the news about the possible beneficial effects of aspirin (ASA) in preventing colon cancer for a number of years now.

Now I'm really excited about the news in this ABC News video, "Fight Cancer With Aspirin." In summary, "Taking aspirin regularly may increase survival rate for those with colon cancer."

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• Colon cancer survival improved with Aspirin (cbc.ca)
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CDC - Brand New 2010 Yellow Book for Travelers - free - online

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When you read this, I'll be travelling. For those of you with international travel plans, you might want to check out this free online resource, the 2010 CDC Traveler's Health Yellow Book.

Although this is written with the health professional in mind, anybody who's travelling can benefit from this wonderful free resource.

Check it out!

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Travelling This Summer? Must read tips! (CDC Traveler's Health Tips)

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• Benefits of International Travel (isparisexpensive.com)

Avoid Summer Sunburn

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I'm on my way out the door for a weekend of fun in the wine country. Some food, wine, and lots of sun. I never used to use much suntan lotion or sunblock, and my nose and cheeks are starting to show it. I just went shopping for some products and picked up some SPF 70. OMG. They even make an SPF 100 now!

Anyhow, here's something that caught my eye last season, for those of you at risk of a worse sunburn:

It is Summer - These things will make your sunburn worse!

Have fun this weekend!

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• Which SPF Is Right For You? (fitsugar.com)

Win A Free FDA GMP Poster!

If you're responsible for QA, GMP training, or just trying to keep some key messages in front of your employees, then this is for you.

SkillsPlus International Inc. recently announced the release of a new product line, "a full and yet growing line of GMP Good Manufacturing Practice and QSR Quality System Regulation posters," that can be found on the Skillsplus Motivational Items page.

Just to sweeten up the pot, they've also just announced a SkillsPlus - Register for a drawing to win a free GMP poster of your choice.

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New GMP Posters Announced

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Fun Health Widgets

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I happened to run across these fun health-related widgets, and thought you might be interested. I've recently rededicated myself to taking a real lunch brunch (versus eating lunch while working at my computer), and taking a few minutes for meditation. That's why I'm interested in these widgets, especially the yoga one.

Checkout these Kaiser Permanente widgets for mind, body, and spirit:

• Yoga
• Brain teaser
• Burn it off! Fitness calculator

Enjoy!

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• Meditations Can Build a Bigger Brain (neatorama.com)