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Fibromyalgia is an increasingly common condition that is characterized by long-term, body-wide pain and tender points in jo

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

ints, muscles, tendons, and other soft tissues. The National Fibromyalgia Association reports that as many as 10 million pe

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

Examples of combination products may in

ple have fibromyalgia, and over 80 percent of those diagnosed are women.

Fibromyalgia can mimic rheumatoid arthritis witho

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

t the swelling and deformity of joints seen in rheumatoid arthritis. Ironically, this is unfortunate since people with this

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

disease look perfectly healthy while feeling so ill.

By far, the chief complaint of fibromyalgia is pain followed closely

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

Combination pro

y fatigue:

*Muscle and joint pain on the neck, shoulders, sternum, lower back, hips, shins, elbows, knees.

*Fatigue *S

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

eep disturbances

*Body aches

*Reduced exercise tolerance

*Chronic facial muscle pain or aching

It is not known what cau

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

es people to develop fibromyalgia. Preliminary studies have hinted that there may be a genetically inherited disposition to

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

develop the disorder, but that is not conclusive.

The clinical management of fibromyalgia leaves much to be desired. Until

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

recent research showed that the pain was real, many doctors referred people with this disorder for psychiatric care. Since

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

ibromyalgia isn't a bacteria, virus, or germ, doctors have a hard time dealing with something they can't see. Some patients

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

Following aspects would a

are helped by anti depressants, but many are not. Traditional treatment options are few.

Fortunately fibromyalgia is one c

dd to the challenges in developing combination products:

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

ndition where alternative medicine can definitely help. Naturopathic doctors feel the fundamentals of disease are malnutrit

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

on, toxins, and stress on the immune system. Things like mercury in tooth fillings, industrial chemicals in the products we

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

use, and various other toxins in our environment magnify each other and affect the immune system so that eventually it does

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

not function properly.

A holistic approach will seek to boost your immune system through detoxification, proper diet, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

upplements in combination with treatments such as chiropractic, acupuncture, and massage. Many people have found relief in

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

hese methods. Fibromyalgia isn't a life sentence of pain and fatigue.

Statements made in this article may not be approved

.

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

y the FDA, and should not be taken as professional medical advice.

Note: You are free to use this article (unedited) on yo

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

Companies that provide selfless information through particip

r web site provided the byline and site attribution (at close of article) remain as-is with live hyperlinks to our web site

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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