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Many people would like to solve the legal immigration problem and stop il

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

legal aliens from entering our country by putting up the giant fence alon

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

Examples of combination products may in

g the United States and Mexican borders. The States of California, Arizo

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

na, New Mexico and Texas are of course where the legal aliens cross. Ove

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

r 60 percent of the legal aliens come to our country from Mexico and anot

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

Combination pro

er 18 percent cross over the Mexican border, as they go through Mexico to

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

get to the United States of America.

But is it feasible to build fence

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

along our borders, as such a fence would cost over $1 billion to build an

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

d would take years to complete. Is that feasible? Some say it must be d

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

one no matter what the cost, because the costs of allowing the legal immi

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

ration into our nation and continuing to allow the illegal aliens to come

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

Following aspects would a

at will could collapse our economy. We have already seen unnecessary st

dd to the challenges in developing combination products:

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

resses on our economic prosperity in the United States of America from th

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

e legal aliens, which are coming for Mexico. It is only going to get wor

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

se if nothing is done. Today the United States Senate and the United Sta

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

es Congress are arguing over what is best to be done.

However, it should

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

Professional from academic institutions, pharmaceutical industries, health care indust

also be noted that the Barbara Jordan Commission had already worked out

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

all the details, but nothing was ever done. Perhaps we should enforce th

.

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

e current laws we have our books rather than make a whole set of new laws

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

Companies that provide selfless information through particip

that we obviously cannot or will not enforce. 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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