Summary - Relationships

Have you ever thought just how young United States of America is in world culture? We didn’t become one country until after the Civil War, and then we were faced with rebui

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

lding a war-torn economy. Our machinery was new and not very well made, and the books we printed were lacking in quality. We continued to depend on England for literature.

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

Examples of combination products may in

It has taken a whole century to catch up. We now have a collection of literature that stands on its own. The children’s books of the twentieth century tell America’s story

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

and help us to appreciate the unique quality of American culture. No other country in the world is anything like us. Yet we represent every other country in the world. We’r

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

e a mosaic, each pixel representing a distinct element, and together a single image.

What does it mean to be an American? It starts with the American dream. It continues w

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

Combination pro

ith a belief that nothing stands in our way. We have the freedom as individuals to go after the dream, whether it’s financial or, as in the case of Dorothy in “The Wonderfu

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

l Wizard of Oz,” finding the way back home. This aspect of being American hasn’t changed, even though finding the way, financially or socially, isn’t always easy. During th

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

e 1930s, we had to face the Great Depression; in the 1940s, a second world war; in the 1950s complacency and a war that we couldn't win; in the 1960s a social revolution 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, again, a war we couldn’t win; in the 1970s a psychological depression; in the 1980s a power struggle, and in the 1990s too much violence. We started out the twentieth c

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

entury involved in an industrial revolution, and we have started the twenty-first with an electronic revolution.

As part of this electronic revolution, we’re finding that

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

new sources of information are changing our view of history. Also, our privacy has been invaded, and we’re finding out a lot more about each other than we need to know. For

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

Following aspects would a

a country that celebrates individual rights, it has taken a long time to recognize the barriers that have made such rights difficult to achieve for some people, namely bla

dd to the challenges in developing combination products:

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

cks, Asians, Native Americans, Hispanics, and, let us not forget, women. I’ve never considered myself a feminist, but I was brought up to believe that being female was a ma

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

tter of pride, not debasement.

Most Americans, with the exception of Native Americans (or “the People,” as they prefer to be called), see themselves as more attached to th

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

eir country of origin, the land of their ancestors, than to America itself. Owning a house is more important than ties to a piece of land. They see themselves as hyphenated

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

Americans--Italian-American, Polish- American, Asian-American, African-American, Hispanic-American. American citizens can trace their genealogy, but if the trace goes back

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

Professional from academic institutions, pharmaceutical industries, health care indust

more than 200 years, chances are they’re going to find themselves in a different country. Even for those claiming ties to the first settlers (European, that is) can’t go b

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

ack more than 400 years.

With the whole world at our fingertips, we tend to ignore much of that world, seeing the American way as the only way. Instead of learning from o

.

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

thers, we try to impose our beliefs on them. We’re rash and outspoken and unafraid to voice our opinions here and abroad. But isn’t that the glory of America, the freedom t

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

Companies that provide selfless information through particip

o speak out? We also have the freedom to listen, and we should do more of it. In the meantime, being an American is a matter of pride, and we wouldn’t have it any other way

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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Summary - What Does It Mean to Be an American

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