Saturday, May 30, 2009

Men - Study Says Drink Wine and Live Longer

This is the kind of news I like to read. As an avid wine enthusiast, it's great to know that my hobby is helping me live longer. For the condensed version of the research results, read this FoxNews article, Study: Light Wine Consumption Lengthens Life. For the heavyweight, full-length journal article of the original research publication, read this, Long-term wine consumption is related to cardiovascular mortality and life expectancy independently of moderate alcohol intake: the
Zutphen Study (pdf)
.

Drink up!

Related Posts:
Epidemiological Reasons To Drink Alcohol For Health
Wine - For Enjoyment Or Metal Ion Poisoning?!
Treat The Flu With Red Wine?!
Drink Red Wine - Live Longer !?

For Wine Lovers:
Wine Lovers Dishwasher Magnet
Champagne In The Freezer - Reminder Magnet
Wine In The Freezer - Reminder Magnet (10 pack)
Ask About Our Wines Magnet (10 pack)

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Wednesday, May 27, 2009

Drugs - Devices - Preemption - Explained Clearly

My hat is off to Matt Hotz, on the Pharma Compliance Blog, for writing this succinct and consumable post that even I can understand, Preemption and the Distinction between Drugs and Devices.

I'm not a lawyer, so I've found this particular topic difficult to digest. Hotz' post got me up to speed quickly and expanded my understanding of the touchpoints to local, state, vs. federal law; and to the distinctions and nuances between drugs vs. medical devices.

Now I feel that I can follow breaking preemption news with some basic foundational understanding. Thanks Matt!

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Monday, May 25, 2009

FDA Guidance - FDA and Sponsor-Applicant Meetings

This FDA guidance, Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants, provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to abbreviated new drug applications. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, or videoconference).

This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. The general principles in this guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible.
This guidance supersedes the guidance for industry Formal Meetings With Sponsors and Applicants for PDUFA Products published February 2000. The 2000 guidance implemented section 119(a) of the Food and Drug Administration Modernization Act of 1997, and reflected a unified approach to all formal multidisciplinary meetings between sponsors or applicants and the FDA.

Related Posts:
Cheerios Aside . . . FDA Gives Guidance On OTC Labels (pdf)
FDA Draft Guidance - Drug Supply Chain and SNIs
FDA Final Guidance On Genetically Engineered Animals
FDA Draft Guidance On Good Importer Practices
FDA Guidance Documents - FDA Current Thinking (free)

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, May 23, 2009

See Clearly - It Is Healthy Vision Month

May is Healthy Vision Month, a national eye health observance devoted to promoting the vision objectives in Healthy People 2010. The focus for this year is Healthy People Vision Objective 28-3: Reduce uncorrected visual impairment due to refractive errors. The goal of Healthy Vision Month 2009 is to promote the importance of getting eye exams. Learn more about Healthy Vision 2009.

Bottomline, it's important to get your eyes checked. Especially if you're not seeing clearly.

For more reading about other things you can do to protect your vision, read this Medical News Today post, "Top 10 Tips To Save Your Vision."

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Wednesday, May 20, 2009

FDA Updates MAPP On Human Research

This FDA Manual of Policies and Procedures (MAPP) establishes the policies and procedures that employees in the Center for Drug Evaluation and Research (CDER) must follow when submitting human subject research for review to FDA’s Institutional Review Board (IRB), the Research Involving Human Subjects Committee (RIHSC), in the Office of Science and Health Coordination (OSHC) within the Office of the Commissioner. These procedures must be followed, and written RIHSC approval or exemption obtained, before initiating any research involving human subjects. This MAPP also establishes policies and procedures pertaining to responsibilities for study conduct and oversight.

This MAPP is a revision of an earlier MAPP originally numbered 4112.6. The MAPP’s change in number reflects the establishment of the Office of Translational Sciences (OTS) within CDER.

Additional FDA Resources:


Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
The Exemptee Institute
The Designated Representative Institute
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Monday, May 18, 2009

Cheerios Aside . . . FDA Gives Guidance On OTC Labels (pdf)

OK, now that we can chuckle about the Cheerios label fiasco, here's the scoop on what should go on OTC labels, "FDA Guidance for Industry - Labeling OTC Human Drug Products (PDF)"

In a nutshell, the Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new over-the-counter (OTC) labeling requirements set forth in 21 CFR 201.66 and prepare new labeling.

If you're new to this arena, you'll find this a real eye opener. The FDA even regulates things down to the detail of what size font you need to use, and more!

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, May 16, 2009

FDA Says Cheerios Makes False Claims

The FDA tells General Mills CEO, "The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA's home page at http://www.fda.gov."

Ooooh, what a spanking! ... as reported in this FDA Warning Letter to Ken Powell, Chairman of the Board and CEO.

Read more about this on this Fox Austin article, "FDA: Cheerios Makes False Health Claims.

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Friday, May 15, 2009

FDA - Transdermal Patches - MRI Burning Risk (Podcast)

A quick re-reminder that not all transdermal patches come with labelling warning patients about the burning risk while undergoing an MRI exam. Listen to this FDA Podcast, Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings, or read the transcript "Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings."

Related Posts:
FDA Warns - Avoid Burning - MRI and Drug Patch Interaction
Duck - It Is A Sandbag - Flying In The MRI Room
Are You Safe In An MRI Machine?

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Wednesday, May 13, 2009

FDA Expected To Rule On Mercury Dental Amalgams

I'm so glad that I don't have mercury fillings in my mouth anymore. Unfortunately, I've got a mouthful of crowns, and precious little left of my natural teeth.

I ran across this press release, and thought you'd be happy to know that the FDA is expected to rule on mercury-containing dental amalgams, "Resolution to Study Phase Out of Mercury Tooth Dental Fillings Receives 16% of Vote at Danaher Shareholder Meeting." The press release states, "Some-time in late July, the Food and Drug Administration is expected to rule on the use of mercury amalgam. The Consumers for Dental Choice won a 10-year battle with the FDA to comply with the law and set a date to classify mercury amalgam."

Related Posts:
Caution - Teeth Whiteners Can Reduce Enamel Strength
Mercury-Containing Dental Fillings - Health and Environmental Concerns

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Monday, May 11, 2009

FDA Publishes Rulemaking Histories For OTC Drugs


If you're in the Over-The-Counter (OTC), non-prescription drug business, then this FDA collection might be of some interest to you: Rulemaking History for Nonprescription Products: Drug Category List.

The Over-the-Counter (OTC) drug category collection contains Federal Register notices organized by therapeutic category subtopics. Each child collection links to therapeutic category pages organized chronologically. Pretty nice. For example, you can scan the Federal Register history for something like, Hair Growth and Loss, Male Genital Desensitizers, or Weight Control.

Related Posts:
FDA Warning - Anesthetics On Skin Can Harm
FDA Alert - Bowel Cleanser Warning
Cold Meds For Kids - The FDA Weighs In Again

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, May 9, 2009

University Researcher Compares Carbon Nanotubes to Asbestos (video)

I found this YouTube video that helps me visualize how asbestos is physically similar to carbon nanotubes (CNT), Are Carbon Nanotubes the Next Asbestos? (video):




Under a microscope, CNTs look identical to asbestos fibers, leading scientists to believe that they could cause similar health problems. In this video, North Carolina State University (NCSU) researcher, Dr. Jamie Bonner, shares his research on the potential toxicity of carbon nanotubes.

Related Posts:
Asbestos.com - HONcode Certified
Reputable Mesothelioma Resources
Are Nanoparticles Dangerous Like Asbestos?

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Friday, May 8, 2009

CDC Says Mesothelioma Deaths Increasing

Morbidity and Mortality Weekly Report (MMWR) reports mesothelioma fatalities over the past several years, Malignant Mesothelioma Mortality --- United States, 1999--2005. In a nutshell . . .

CDC's National Institute for Occupational Safety and Health (NIOSH) analyzed annual multiple-cause-of-death records for 1999--2005, the most recent years for which complete data are available. For those years, a total of 18,068 deaths of persons with malignant mesothelioma were reported, increasing from 2,482 deaths in 1999 to 2,704 in 2005. The agency expects the number of mesothelioma deaths to peak next year, and to begin to decline, as the improvements in safety and reduction in asbestos use instituted decades ago payoff. The latency period of mesothelioma can be decades long, so even though asbestos is used less widely today, people continue to get mesothelioma due to their exposure in the past.

What's concerning is, "Recent studies suggest that carbon nanotubes (fiber-shaped nanoparticles), which are increasingly being used in manufacturing (9), might share the carcinogenic mechanism postulated for asbestos and induce mesothelioma (10), underscoring the need for documentation of occupational history in future cases. Capturing occupational history information for mesothelioma cases is important to identify industries and occupations placing workers at risk for this lethal disease."

Related Posts:
Asbestos.com - HONcode Certified
Reputable Mesothelioma Resources
Are Nanoparticles Dangerous Like Asbestos?

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Wednesday, May 6, 2009

Swine Flu - Be Happy - - - FDA Worries About Mad Cow Disease - BSE

The world is a dangerous place. Where can you go to escape the scourge of swine flu?! OK, a little melodramatic. In any event, the U.S. Food and Drug Administration (FDA) released a final guidance document April 30 about the substances prohibited for use in animal feed, relating to its new rule to protect against bovine spongiform encephalopathy (BSE). The so-called BSE rule became effective April 27, but renderers will have additional time to comply with new requirements. The FDA's established compliance date is Oct. 26. The new guidance document should help slaughter facilities and farms supplying offal and dead livestock to renderers to understand their responsibilities in regard to the new rule.

Feeling any safer?!

FDA Reference Documents:
FDA Issues Final Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed
GUIDANCE FOR INDUSTRY SMALL ENTITIES COMPLIANCE GUIDE FOR RENDERERS—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED (pdf)
FDA Page on Bovine Spongiform Encephalopathy (BSE)

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Monday, May 4, 2009

Medical Devices Infected By The Conficker PC Worm

Be very afraid. Hospital and medical devices have been found to be infected by a computer worm (kind of like a virus), reports this Mercury News article, Conficker worm hits hospital devices, "A computer worm that has alarmed security experts around the world has crawled into hundreds of medical devices at dozens of hospitals in the United States and other countries, according to technologists monitoring the threat."

What I find so disturbing in the article is, "the working group has seen thousands of other machines located in hospitals reach out to the Conficker mastermind by contacting another computer on the Internet for instructions." The potential danger could be leaking of your health information, or the medical devices could be recruited as robots in an attack on other computer systems.

Isn't technology grand!?

Related Posts:
Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)
2009 - Top 10 Trends For The Medical Equipment Market

Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Saturday, May 2, 2009

Start HIV Meds Early - Live Longer

This Medical News Today article reports, "Early Initiation Of Antiretroviral Therapy Improves HIV Survival Rates, Study Says." The study results are available on the New England Journal of Medicine (NEJM) site, "Effect of Early versus Deferred Antiretroviral Therapy for HIV on Survival. This recent research "provides evidence that patients would live longer if antiretroviral treatment was begun when their CD4+ count was above 500."

As with these kinds of studies, there's also the counterpoint opinion, such as this editorial, "When To Start Antiretroviral Therapy: Ready When You Are?" .... darn, NEJM truncated it... go back to the Medical News Today article, they summarize the gist of the editorial.

Related Posts:
New Guidelines Released for HIV Opportunistic Infections
HHS Updates HIV Treatment Guidelines (free pdf)
Flash - HIV Drug Treatment Needs To Start Earlier

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

Friday, May 1, 2009

Swine Flu Increases Demand For Masks (video)

I'm not too happy. It's not about whether wearing a face mask might protect me from catching the flu. It's all about, if I want to wear one, that's my choice. The rub is, I've been into many corner drug stores, and can't even buy one if I want to. The store shelves are empty. The masks are sold out.

This ABC News video just adds insult to injury for something I already know, Swine Flu Increases the Demand for Masks.

Here's hoping that if you want to wear a mask, that you can find some to buy.

Related Posts:
FDA - Flu Meds and Swine Flu Tests
Say No To Colds - How To Wash and Dry Hands
Treat The Flu With Red Wine?!

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/

From SkillsPlus International Inc.

Custom Search

Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
    GMP Training Gifts & Giveaways