FDA Cracks Down on Fake Cures

Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit
Written by: Norm Howe | Distributed: 2011-09-12 | Word Count: 706 | Page Views: 537
Medical device manufacturers are always interested in knowing what FDA's next area of focus will be. Well, if you're an In Vitro Diagnostic manufacturer you might review your measurement systems.

How to Evaluate the Quality of a Dietary Supplement
Written by: Norm Howe | Distributed: 2010-11-02 | Word Count: 751 | Page Views: 5406 | Votes: 7 | Rating: 0.57
So, you've found a Dietary Supplement that exactly fits your special need. The information on the supplier's website appears to be consistent with everything that you've read and heard, and now you're ready to buy. But there are questions on your mind. "What is the quality of this product that I'm buying?" you ask. "Can I really trust this supplier?"

Off-Label Use of Medical Devices
Written by: Norm Howe | Distributed: 2010-06-22 | Word Count: 621 | Page Views: 6061 | Votes: 3 | Rating: 1.67
How can a medical practitioner decide whether a medical device that they want to use for one of their patients is legal and approved by the Food and Drug Administration? When a patient comes into a physician's office the patient is looking for the best, most modern care they can get. And a physician certainly wants the same thing.

A New Paradigm to Address the High Cost of Vendor Qualification
Written by: Norm Howe | Distributed: 2010-01-12 | Word Count: 1160 | Page Views: 4492 | Votes: 6 | Rating: 1.17
The assumption today is that a BETTER audit means a LONGER audit. There has to be another way. What's needed is a new paradigm for vendor qualification; a tool that can drill deeply into the vendor's operation at low cost; something that can provide a more lasting measure of the vendor's performance than simply an audit...

FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe | Distributed: 2009-03-10 | Word Count: 666 | Page Views: 5303 | Votes: 9 | Rating: 0.67
The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..." But when different people from different backgrounds work together, disagreements can stall your team. How do you get your project back on track?

The Myth of the Generic SOP
Written by: Norm Howe | Distributed: 2009-03-03 | Word Count: 687 | Page Views: 4877 | Votes: 8 | Rating: 2.00
What do you do when your boss tells you to write an SOP? Run and hide? Tell her how long it will really take to write one that's any good? If you choose the latter option, be prepared for this "helpful suggestion": "Why don't you just download a generic SOP from the internet?" You would have been better off taking the former option. Here's why.

The Evolution of Process Validation
Written by: Norm Howe | Distributed: 2009-01-27 | Word Count: 471 | Page Views: 6663 | Votes: 15 | Rating: 1.53
In November 2008, the U.S. Food and Drug Administration (FDA) published draft guidance on process validation. Entitled Process Validation: General Principles and Practices, this draft guidance replaces the previous guidance issued in 1987. What does this mean to you?

FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe | Distributed: 2009-01-21 | Word Count: 665 | Page Views: 6488 | Votes: 9 | Rating: 2.78
The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..." But when different people from different backgrounds work together, disagreements can stall your team. How do you get your project back on track?

Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers
Written by: Norm Howe | Distributed: 2009-01-05 | Word Count: 440 | Page Views: 4484 | Votes: 8 | Rating: 1.38
How do small Dietary Supplement manufacturers comply with the new Dietary Supplement GMPs? The U.S. Food and Drug Administration (FDA) announced plans to publish a compliance guide that will provide assistance to small dietary supplement manufacturers.

Dietary Supplements Must Be Tested by Scientifically Valid Methods
Written by: Norm Howe | Distributed: 2008-09-03 | Word Count: 424 | Page Views: 5550 | Votes: 8 | Rating: 0.88
Are you a Dietary Supplement manufacturer trying to figure out what FDA means by "Scientifically Valid Method"? Here are some hints.

All of Author's Articles on this site: Norm Howe Articles

The Powerful Antioxidant You Cannot Eat Or Drink
Written by: Nate Rifkin | Distributed: 2011-07-20 | Word Count: 499 | Page Views: 4408 | Votes: 1 | Rating: 1.00
There's no need to eat or drink anything to activate your body's powerful antioxidant to prevent free radical damage. You'll end up healthier inside and looking better on the outside as well.

3 Bacterial Vaginosis Remedies You Can Start Using Today
Written by: Louise Endago | Distributed: 2011-07-20 | Word Count: 867 | Page Views: 7841 | Votes: 5 | Rating: 1.20
Very few women are successful at treating bacterial vaginosis using one treatment alone. The secret lies in using a combination of treatments that complement one another. In this article you will discover 3 such remedies that give excellent results.

Encouraging Healthy Children with Outdoor Play Sets and Activities
Written by: Giana Briggs | Distributed: 2011-03-17 | Word Count: 410 | Page Views: 6740 | Votes: 5 | Rating: 0.40
Having a play set in your backyard can be a great way to get your child off the couch and out into the fresh air. With childhood obesity on the rise, we need to do what we can as parents to get our children active and enjoying playing and interacting with each other children again. Being able to go out in the yard and have something to do is just one small step in the right direction.

How to Recognize Anxiety in Children and Adolescents
Written by: Dr Jeannette Kavanagh | Distributed: 2010-12-28 | Word Count: 836 | Page Views: 7027 | Votes: 4 | Rating: 1.00
Problems with a too-high level anxiety can start in childhood with children and adolescents worrying to a greater extent than their peers about all sorts of things. Some behaviors are an indication of a fussy and over tidy child. When we go just a little bit over fussiness and we have entered the realm of an anxiety disorder.

How to Tell if You Have Anxiety Disorder
Written by: Dr Jeannette Kavanagh | Distributed: 2010-12-23 | Word Count: 1093 | Page Views: 7041 | Votes: 5 | Rating: 1.20
If you're someone who can never earn enough or have enough money to relax about it, and to enjoy spending it, you may have underlying anxiety problems that you haven't had to face, or you haven't wanted to face.

How to Tell the Difference Between Anxiety and Normal Worry
Written by: Dr Jeannette Kavanagh | Distributed: 2010-12-21 | Word Count: 979 | Page Views: 6564 | Votes: 5 | Rating: 0.40
Anxiety is a normal feeling people experience when faced with threat, danger or stress. Feeling anxious can sometimes be a good thing. Occasional anxiety is part of normal life. However, for some people anxiety is a constant factor in their lives. When a person has anxiety problems, it interferes with their ability to function normally on a daily basis. Anxiety disorder can cause people to feel intense, long-lasting fear or worry, in addition to other symptoms.

How to Treat Your Anxiety and Panic Attacks
Written by: Dr Jeannette Kavanagh | Distributed: 2010-12-16 | Word Count: 742 | Page Views: 6616 | Votes: 7 | Rating: 0.86
Next to Depression, one of the most common disorders which affects an estimated 2.4 million people in America alone, is anxiety disorder. Anxiety can manifest as a generalized anxiety, panic attacks, social anxiety and agoraphobia. Anxiety disorder can be mild or so totally disabling that the person is confined to her or his home. All forms of anxiety can be extremely frightening to those who experience it frequently, but many individuals have found comfort in the fact that anxiety disorders can be treated.

Anxiety Disorder and Panic Attacks: How Cognitive Behavior Therapy Can Help You
Written by: Dr Jeannette Kavanagh | Distributed: 2010-12-09 | Word Count: 748 | Page Views: 6709 | Votes: 4 | Rating: 0.25
In your journey to conquer anxiety and to eliminate panic attacks from your day-to-day life, no one approach will be totally right, but Cognitive Behavior Therapy can be a very powerful part of your recovery. In this short article, I want to explore what's involved in Cognitive Behavior Therapy, so that you can make a decision whether or not you'd like to explore it with your therapist.

Losing Weight - The Addiction of Comfort Food
Written by: Larry Tobin | Distributed: 2010-11-04 | Word Count: 863 | Page Views: 6395 | Votes: 3 | Rating: 0.00
Its very name is appealing - comfort food. What could be more wonderful than a food that helps us feel better? Almost everyone can name something that they eat when they're just feeling sour or sad. Of course, we know that food can't be the solution to our problems, especially the problem of trying to lose weight and keep it off. So why do we find ourselves trapped in the eat/feel better/feel worse/eat some more cycle?

Understanding the Roles of Respite Caregivers for Seniors
Written by: Bob Fischer | Distributed: 2010-11-02 | Word Count: 582 | Page Views: 5239 | Votes: 3 | Rating: 0.67
Caregivers for seniors are typically paid providers but they may also be volunteers from a government or nonprofit organization. Where care is being provided in the home there is often a mix of formal and informal care provided. And the trend is towards using more formal care since, unlike the past, more informal respite caregivers are employed. Read on.

Bone Density and Your Well Being
Written by: Kamau Austin | Distributed: 2006-06-15 | Word Count: 685 | Page Views: 51688 | Votes: 47 | Rating: 2.55
We spend a lot of time and energy thinking of ways to reduce our weight but we need to think about the bones that form the basic structure of the very same body. Bone density is an important factor in helping us stay young and on our toes. Bone density needs to be checked as we age and if found low, adequate measures need to be taken to improve it.

President Given the Cure for Herpes and Cold Sores ?
Written by: James Kaylon McIntyre | Distributed: 2006-11-09 | Word Count: 404 | Page Views: 33419 | Votes: 25 | Rating: 2.24
Viraway was founded by a man who is in his 70s today. As a Young man he suffered from acute cold sores. The discomfort was so severe that he thought they would never go away. A native American Indian gave him a tribal mixture of herbs and told him that this mixture would eliminate the cold sores with in two weeks...

Oyster Extract Improves Men's Sexual Health
Written by: Stephen Kavanagh | Distributed: 2008-06-26 | Word Count: 851 | Page Views: 28654 | Votes: 61 | Rating: 3.41
Description of the benefits of taking oyster extract powder for good sexual health in men and women. Details of the features and benefits, the different brands, the alternatives and advice on choosing the right oyster extract product.

How to Force Your Body To Melt Fat Like Butter In A Microwave
Written by: Robert Kokoska | Distributed: 2008-04-08 | Word Count: 613 | Page Views: 22805 | Votes: 37 | Rating: 2.62
There are a couple of very simple changes you can make to the way you eat that will force your body to become a fat burning furnace and cause you to easily drop your unwanted pounds day after day.

Losing Weight Without Gaining Stretch Marks
Written by: Kamau Austin | Distributed: 2006-12-11 | Word Count: 579 | Page Views: 22024 | Votes: 47 | Rating: 2.70
Few things can make us as elated as seeing the pounds melt way through our efforts of eating less and exercising more. We gain new confidence and vitality as we watch our waistlines reappear and become reacquainted with the tops of our feet. But as the weight falls away we can be plagued by a new assault - one we did not see coming - stretch marks.

Is Retinol Good for Your Skin?
Written by: Craig Elliott | Distributed: 2007-10-04 | Word Count: 576 | Page Views: 19559 | Votes: 48 | Rating: 2.60
These days, whether you have wrinkles or you are certain that you will get them in the near future, it is hard to ignore the hundreds of new anti aging products on the market. With retinol and AHAs, BHAs and vitamins, it's hard to tell which products are actually going to work and which ones are will not. While a lot of the success rate depends on the unique qualities of your skin, there are scientific studies that have shed light some of the more popular skin treatments.

Mold Spores In Your Home - How Much Is To Much
Written by: Daryl Watters | Distributed: 2007-05-15 | Word Count: 866 | Page Views: 19432 | Votes: 35 | Rating: 3.03
Health responses to mold spores can be affected by the length of time you are exposed to spores, the size or type of spore you are exposed to, the levels of dust mite and roach allergens, individual sensitivity to allergens, emotional stress, general health, as well as other substances and factors that have not yet been discovered by mold inspectors. Thus, as a result mold spore levels alone at your property cannot always be relied on to always answer questions such as "Are molds in my environment making me sick."

Causes for Yellow or Dark Brown Poop - Symptoms of Healthy Poop - Dr Oz's Tips to Diagnosis Yourself and Self Help
Written by: John Khu | Distributed: 2009-12-29 | Word Count: 545 | Page Views: 16538 | Votes: 18 | Rating: 1.94
Now the question arises how to detox your body? Body toxins are accumulated due to improper food consumption; sedentary lifestyle also causes digestion problem and heavy metal toxins to accumulate in our body. Therefore, in order to avoid bowel problem, your body needs to heavy metal detox.

What Does a Stun Gun Do to the Human Body?
Written by: Fred Cheney | Distributed: 2008-01-02 | Word Count: 494 | Page Views: 16412 | Votes: 29 | Rating: 3.03
The word "stun" has a mysterious ring to it. It is synonymous with words like "overwhelm," "stupefy," and "daze." What do these words really mean? In other words, what would happen to your victim if you touch him with your stun gun? What would happen to you if you stunned yourself? Could someone be permanently injured, or worse, die? To sum it up: What are the effects of a stun gun shock? These are all important questions - questions with solid answers.

14 Causes of Constipation
Written by: Howard Richman | Distributed: 2008-12-02 | Word Count: 1642 | Page Views: 16271 | Votes: 13 | Rating: 2.85
For people who know all about drinking liquids and eating fiber but still have never been able to break free of their curse of constipation, this article offers many other considerations that will help the reader find solutions to lifelong constipation.

Which Full Face CPAP Mask is Best for You?
Written by: Chris Vasta | Distributed: 2009-09-01 | Word Count: 690 | Page Views: 9658 | Votes: 12 | Rating: 3.42
If you've been diagnosed with Sleep Apnea, you are undoubtedly trying to narrow the choice of masks. If your mouth opens during sleep, one option would be full face CPAP masks. The full face CPAP mask is used to deliver pressure through both the nose and mouth. Trying to decide which full face CPAP mask to use can be complex and expensive. The number of mask options available is confounding. Based upon comfort, fit, good seal, and durability, we recommend the following three full face CPAP masks.

Oyster Extract Improves Men's Sexual Health
Written by: Stephen Kavanagh | Distributed: 2008-06-26 | Word Count: 851 | Page Views: 28654 | Votes: 61 | Rating: 3.41
Description of the benefits of taking oyster extract powder for good sexual health in men and women. Details of the features and benefits, the different brands, the alternatives and advice on choosing the right oyster extract product.

What Makes Tea So Effective At Preventing Heart Disease?
Written by: Jon M. Stout | Distributed: 2007-02-02 | Word Count: 812 | Page Views: 4578 | Votes: 9 | Rating: 3.22
Many bodies of research have shown that tea is effective at preventing heart disease in several ways. Tea prevents the oxidation of LDL cholesterol into plaque, the hard substance that clogs our arteries, making us more susceptible to heart attacks and strokes. Tea is also thought to have an anti-inflammatory effect, which helps the heart in its overall function.

Green Tea May Positively Effect Stomach Cancer in Habitual Tea Drinkers
Written by: Jon M. Stout | Distributed: 2006-11-06 | Word Count: 535 | Page Views: 4097 | Votes: 11 | Rating: 3.18
Stomach Cancer is the second-leading cause of cancer-related deaths in the Western World. In fact, the American Cancer Society estimates that 22,228 Americans will be diagnosed with stomach cancer during 2006. They also project that there will be an estimated 11,430 deaths from this type of disease. Therefore, the search for a cure for this disease has been a long standing one. In the past, clinical researchers have hypothesized that drinking green tea may indeed inhibit stomach carcinogenesis, and a few case-studies with animals and human beings have successfully broadened this theory.

A Comparison of Tattoo Removal Methods: Tattoo Removal Skin Peels Vs Tattoo Removal Creams Vs Tattoo Removal Using DermaBrasion
Written by: Abe Granberry | Distributed: 2009-09-30 | Word Count: 1821 | Page Views: 8312 | Votes: 17 | Rating: 3.18
A friend and I, along with 3 other buddies, decided to try an experiment to remove tattoos that we have all had for many years. Over time we just decided we no longer liked what we saw on our arms, shoulders and chest so we decided to test all the varieties of tattoo removal except Laser because none of us could afford the price, plus we wanted to see for ourselves if the other products actually worked or were just marketing hype.

Colon Cancer: Risks and Prevention
Written by: Abel Travers | Distributed: 2007-12-13 | Word Count: 785 | Page Views: 3960 | Votes: 6 | Rating: 3.17
Cancer: it's not a word that anyone really wants to hear. While not necessarily a death sentence, cancer is an illness that does have a high mortality rate depending on where in the body it strikes. Read on as we examine what can be done to head-off Colon Cancer, the third most common cancer.

Body Detox Tips: The Dos and Don'ts
Written by: John Khu | Distributed: 2008-12-23 | Word Count: 496 | Page Views: 3429 | Votes: 12 | Rating: 3.17
Most people know about detoxing, but do they know that there are things that we should and shouldn't do? If not, we will share some body detox tips today so that they will know whenever they decide to go on with a detox diet.

Stress is a Killer... Will it get YOU?
Written by: Dr. Rich Starr, PHD Psychology | Distributed: 2004-10-05 | Word Count: 1223 | Page Views: 3001 | Votes: 7 | Rating: 3.14
I have read a number of times that the medical profession does not know why a preponderance of heart attacks occur on Monday morning throughout the world. I believe I have found an answer to this riddle. This Killer Monday Morning Syndrome comes about, I believe, because most people have Saturday and Sunday off from work. Because of this time off from work this gives them more additional time to think about things and therefore add more additional things to their to do list, and presto they wake up Monday morning full of stress and nervousness and don’t realize or know why.

Taking the Shame out of Pudendal Neuralgia!
Written by: Violet Matthews | Distributed: 2006-10-26 | Word Count: 1170 | Page Views: 6826 | Votes: 22 | Rating: 3.14
Chronic pelvic pain has affected 15-30 percent of women and men in the world. Finding a diagnosis and treatment can be quite challenging. Some women and men with chronic pelvic pain have a very rare disorder called pudendal neuralgia. Learn about the diagnosis, treatments and outcomes from this extremely painful neuralgia.

Breast Enlargement Through Natural Herbal Supplements - Is It Safe?
Written by: Asep Komara Sanjaya | Distributed: 2008-03-11 | Word Count: 342 | Page Views: 2618 | Votes: 14 | Rating: 3.14
Are you interested in larger breasts? Are you trying to take your look to the next level? If so, you are not alone. There are thousands of women the world over who are interested in larger breasts. Not only do they think that this is attractive, but they also know that men love this as well. But when it comes down to it, enlarging your breasts is not always the easiest thing to do.