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The current number of immigrants in the country is about 37.46 millions and the 32% remains illegally in the US territory1. According to the Border Protection, Counter-Terrorism, and Illegal Immigration Control, approv

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

ed last year by the government, the aliens who work and live undocumented in the country will have strong and drastic penalties, but how hard will be the stroke of missing such a great quantity of consumers and entrepr

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

Examples of combination products may in

neurs, as immigrants are, for the US economy?

As shown by studies done in the last year, the contribution of immigrants in the US economy is everything but insignificant. One of the conclusions of a national survey co

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

missioned by the National Venture Capital Association and made by Stuart Anderson and Mary Platzer last year was: "Immigrant entrepreneurs and professionals contribute significantly to job creation and innovation ... s

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

hows the striking propensity of immigrants to start and grow successful American companies 2.

In a research made by the UC Berkeley School of Information and the Duke University the numbers confirmed that: ..."the 25.

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

Combination pro

% of the engineering and technology companies started in the U.S. from 1995 to 2005 and at least one key founder was foreign-born... nationwide, these immigrant-founded companies produced $52 billion in sales and emplo

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

ed 450,000 workers in 2005...immigrants have become a significant driving force in the creation of new businesses and intellectual property in the U.S."3.

Meanwhile other immigrants have become employees in constructi

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

on, landscaping or restaurants doing their job for lower salaries that allow having better prices for the customers. Some managers accept that without these conditions it would be harder and more expensive to face the

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

hallenges in those markets.

Other important matters are the business focused on the immigrants needs like the international calling cards, specialized supermarkets or restaurants. These projects grew due to the purcha

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

ing behavior of the immigrants. The number of immigrants is not that significant to spoil the US economy but it is pretty enough to change small industries into profitable enterprises.

Now not only the aliens are the

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

onsumers of these products and services but also the Americans can supply their needs with the emerging market.

An illustrative case is Viapin.com, a

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

Following aspects would a

title="Calling card list from Viapin" target="_blank">prepaid phone cards company that started in Virginia in 2004 and reached almost 1.000 customers in the first year; today other 19.000 buyers have joint them. T

dd to the challenges in developing combination products:

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

e idea of the business was to provide a service for immigrants so they could contact their families around the world. Now not only Latin-American, African, Asian and European immigrants use their service but also the N

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

rth Americans purchase Viapin's products to call soldiers, students or relatives who are temporary outside the country. The company's annual sales are about $516 thousand dollars4.

The U.S. News & World Report found o

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

ther example of a business created for immigrants in New Jersey: Alfredo Rodriguez owns a 53,000-square-foot supermarket; he transformed it to experience with the tastes of Hispanic shoppers five years ago. Nowadays 90

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

of his customers are Latin American immigrants, and the purchases of 5,000 buyers who visit his store weekly enhance his annual sales to $9 million dollars5.

The question if the lack of immigrants affects or not the

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

Professional from academic institutions, pharmaceutical industries, health care indust

S economy should be first answered by us: immigrant's employers or employees, immigrant's customers or sellers and also immigrant's neighbors, who daily deal with the situation.

A reform that involves the businesses a

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

round the immigrants should take these topics into consideration before putting the last period. Immigration is a very significant phenomenon that some how have got in our society, so we have two options, either go aga

.

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

nst it or take economic advantage of it.
1. Foreign-Born Population of the United States from the American Community Survey in www.census.gov
2. The Impact of Immigrant Entrepreneurs and Professionals on U.S.

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

Companies that provide selfless information through particip

Competitiveness, in www.nvca.org
3. America's New Immigrant Entrepreneurs in memp.pratt.duke.edu
4. Viapin.com
5. Immigrants: the Unsung Heroes of the U.S. Economy, Money & Business, in www.usnews.com

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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Property tax spceicialist, Arthur Weller and Property Investor Amer Siddiq, reveal tax saving tips strategies and secrets to help you beat the taxman and boost your profits.

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