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Just the other day the United States of America’s President George Bush admitted that rounding out

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

all the illegal aliens in the country and taking them back to Mexico was not feasible. In fact he

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

Examples of combination products may in

s correct there is no easy way to roundup that many millions of people and take them back to Mexico

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

it is impossible and would take ten years to roundup everyone.

So what do we do with 24 million i

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

legal aliens anyway? In what we do with a half one million illegal aliens which, to our nation eve

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

Combination pro

y quarter? Well perhaps this excerpt below from an article I wrote in 1999 might shed some light on

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

the subject?

“We need to fix this problem now, educate those here, and help them to live as equals

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

for equal wages and to raise their families with the standards of quality of life we all enjoy. But

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

they must enter the tax system, pay a fine for illegal entry, get their health shots and enroll in

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

nglish classes. And for Mexico, well we need to help our foreign neighbors build infrastructure to

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

row their own economy along side of us, then less people will be wanting to come here to build a be

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

Following aspects would a

ter life and they can simply stay there to enjoy a great life. Besides many American Businesses co

dd to the challenges in developing combination products:

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

ld use another close market as nice as ours. We have that with our Canadian NAFTA Partners. We ca

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

not afford to get rid of our own middle class now, by wavering on immigration rules. Later in the

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

uture we will create welfare problems, health insurance problems, and separation of classes, drains

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

on educational systems, law enforcement problems, and transit problems. And not now, but in a few

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

Professional from academic institutions, pharmaceutical industries, health care indust

ears a terrible employment crisis, and down turn in the quality of life and our standard of living,

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

of course, what the hell do I just wash cars.”

Interesting isn’t it, I guess I even predicted the

.

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

001 economy fall. Well, as you can see we have the same problems still and the crisis is now worse

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

Companies that provide selfless information through particip

nd something must be done soon to avert a bigger economic crisis you see? Consider all this in 2006

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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