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By reviewing the history of America, we will realize that American exceptionalism is stemming in American early history. In 1630, John Winthrop governor of Massachusetts Bay colony, in the Tea Party brought an Idea of "City upon a hill" (Ferrie, 2005; 2). Since then America has been defined as a unique l

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

and for Americans which still this idea exists. That is why some countries like France are opposing Globalization because they considered it as Americanization.

What will happen in the era of Globalization and post modern theories? Will American exceptionalism be threatened by Globalization and is Globa

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

Examples of combination products may in

lization Americanization? In this article I will answer these questions and the reason I will talked about Americanization is that I think this term is a connection between American exceptionalism and Globalization.

Definition

American exceptionalism is a historical phrase that was first used by

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

Alexis de Tocqueville in 1831. Basically it refers to a perception that United States is qualitatively superior to other developed nations for its "unique origin, national credo, historic evolution and distinctive political and religious institutions" (Wikipedia www page, 2006).

Americanization is the t

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

erm used for the influence the United States of America has on the culture of other countries, substituting their culture with American culture. When it is encountered voluntarily has positive connotation and while is unwillingly has negative meaning (wikipedia www page, 2006). Americanization actually i

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

Combination pro

s a complex word in modern cultural criticism and indicates two issues:

1.cultural criticism
2.International communicative debates (Biltereyst, 2002; 4); Featherstone defined globalization and referred it to:
1.An intensified world compression of the world
2.Our increasing conscious of t

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

he world ( Barker, 2000; 167)

Globalization is constituted by abundance of global connections (such as World Wide Web, telephone, advertisements, TV, video CDs and etc) and understanding of them. Since 1970 we have witnessed an era of accelerated globalization.

Americans identify themselves more st

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

rongly than the people in other democracies. About 71% of Americans are "very proud" of living in America. This is by the way that only 38 % of French and 21 % of Germans and Japanese are proud of living in their own countries (Wilson, 2006; 1). Three-froths of Americans believe that spreading American c

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

ulture around the world is a good idea but just one-forth of French think the same about French culture. By this brief statistic we can realize the depth of American exceptionalism among Americans. Even George Bush senior in January 29th 1991 said:" we are American; we have unique responsibility to do th

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

e hard work of freedom and when we do, freedom works" (Sellevold, 2002, 46).

About Globalization, Herbert Schiller indicated that the global communication industries are dominated by US-controlled corporations (cited by barker, 2000; 171) and about two-third of global movies are American (Zonis, 1999; 8

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

). As we know Coco Cola, Mac Donald, Jeans, KFS restaurants which are wide spread around the world are American Originally. Arthur Koestler in his book "The Lotus and the Robot" defined Americanization as coco colonization (wikipedia WWW page, 2006).

Some countries like France are opposing Globalizatio

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

Following aspects would a

n for they dislike Americanization and like to preserve their French orientation .Jose` bove` was the first French who opposed Mac Donald (Felsing, 1999; 8).Americanization has a Fear of vulgarity, commercialization, mass mediated and standardization for the countries who are Anti-Americanist like France

dd to the challenges in developing combination products:

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

and some Middle Eastern Muslim countries like Iran (Biltereyst, 2002; 1). Fear of homogenous culture of America is the reason of this hate. But by arrival of Globalization and post modern theories American culture lost its highlighted impact. The idea of post colonial and post modern era changed and re

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

duced influence of American culture. Giddens in 1999 brought a nice definition of Globalization and Americanization. He believed that people who are out of Europe and North America see globalization as westernization or Americanization (Biltereyst, 2002; 3).

I believe Globalization is not Americanizatio

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

n necessarily. Because we do have many global products which are embedding in different people's life style which are not American like Toyota (Japan), Clothes (china), Nokia cell phones (Finland) or Pizza (Italy), do we consider it as Japanezation or Chinization or Finlandization or Italization?

Mille

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

r also said that Hollywood is global because it is adapting itself to Global changes to have more dominance around the world (Biltereyst, 2002; 9). Generally, globalization is not monolithic one way flow from west to the rest (Barker, 2000; 173). Each nation has a portion in this process, the more power

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

Professional from academic institutions, pharmaceutical industries, health care indust

your have the more changes you will make in the world. We have seen impacts of non-western ideas on the west as well such as:

1.Spreading religion of Islam in the world.
2.Exportation of telenovelas from Latin American countries to other parts.
3.Sale of ethnic foods and cloths.

As a Conc

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

lusion, I don’t want to ignore the influence of American culture in the world but I think Globalization will Perl influence of American dominance and in some cases will do the same about American exceptionalism but this is just in some levels. It will not ruin the whole role. Because I believe global pro

.

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

ducts will become localized in some degrees to be able to be used in each country so American exceptionalism which is embedded in those products will be low lighted. Like censorship of pornographic parts of Hollywood films in Iran or even translation can sometimes change the encoded meanings in the film.

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

Companies that provide selfless information through particip

The way we use internet can not exactly be the same as Latin American's usage. Although the means are the same, we pursue different purposes. I label it as localization of the global so during the localization process some encoded meanings like American exceptionalism will loose their original functions

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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