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The National Institute of Health has finally recognized the seriousness of chronic fatigue syndrome. Last week, it launched a major campaign to

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

create awareness of this illness that is so misunderstood and often misdiagnosed.

This is an illness that is shrouded in mystery, difficult to

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

diagnose and therefore treat. People who suffer from depression often complain about feeling tired and lethargic. The campaign hopes to help pa

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tients know they have an illness that requires medical attention and help physicians be able to diagnose the illness, and be able to validate an

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

d understand the incredible suffering that many people and their families experience in this context.

What is the definition of Chronic Fatigue

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

Syndrome?

According to the Centers for Disease Control and Prevention(CDC), there are two criteria.

1. Have severe chronic fatigue of six mon

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ths or longer duration with other known medical conditions excluded by clinical diagnosis; and

2. Concurrently have four or more of the followi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

g symptoms: substantial impairment in short-term memory or concentration; sore throat; tender lymph nodes; muscle pain; multi-joint pain without

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

swelling or redness; headaches of a new type, pattern or severity; unrefreshing sleep; and post-exertional malaise lasting more than 24 hours.

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

This is a very ambitious campaign and the NIH and CDC (Centers for Disease Control and Prevention) is taking the illness very seriously. The ca

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

mpaign will consist of public service announcements, brochures, a "tool kit" for health-care professionals and a photo exhibit called "The Faces

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

of Chronic Fatigue Syndrome," which will travel to cities across the country throughout 2007.

The Chronic Fatigue and Immune Dysfunction Synd

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ome (CFIDS) Association has been established in Washington, D.C. The Association hopes that it will be a turning point in the public's awarene

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ss of the disease as well as in health-care professionals' ability to diagnose and treat it. I encourage you to get the "tool kit" directly from

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

the CFIDS web site.

This illness does not get the respect it deserves. The general public is more likely to call a sufferer "lazy" or "not-mot

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ivated", rather than encourage them to seek help. With the new brain imaging techniques, scientists can identify changes in the brain structure

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

of people with CFIDS. The brain hormone systems of people with CFS are different than those without the disease. Brain functioning is also impai

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

red and cells' energy metabolism seems to be compromised.

Although chronic fatigue syndrome is not a form of depression, many patients get dep

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ressed because of the illness. CFS patients must learn to pace activties, work and to follow the treatment plans of their healthcare practione

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

r. CFS is finally getting the respect it deserves within the medical community. Do yourself a favor and speak to your doctor about your symptoms

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Demographics can make a big difference in who you choose to be your celebrity endorser. Make sure your choose is the the choose that fits your demographics.

Choosing your business structure is just as important - if not more important - than marketing. You should consult with your accountant or your attorney in forming your business. The process in setting up your company is as follows; these are just the key points that need to be done, but not necessarily in the exact order listed.

What makes the difference between a free and a paid information product (or information providing service) for the same topic ... have you ever thought of that? If not, then read this article.

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