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As a lad of five years, the first life-changing event I faced was December 7, 1941 when President Franklin Delano Roosevelt announced to the Nation on radio (no TV then) that the Japanese Empire ha

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

d staged an unprovoked air attack on our naval base Pearl Harbor in the Hawaiian Islands. Many American military lives were lost and our entry into WWII was declared. Growing up in wartime, I learn

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

Examples of combination products may in

d very early in life what the “American Spirit” was all about. At my young age, it was difficult to understand why our young men and women had to die in a distant land. I eventually came to underst

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 that they were sacrificing their lives so that I could grow up safe and secure in a country that values freedom, independence and the opportunity to make choices.

History will record, as it ha

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

throughout my life, that as tragic and despicable the events of September 11, 2001 were, the determination, will and resolve of the American people will prevail. We will always remember the heroes

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

Combination pro

who inspired us to move on with a renewed sense of importance in our personal and professional lives. The accounts of unselfish heroism will require a separate book from the collection of history b

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

ooks.

The same characteristics that define our American spirit also define our entrepreneurial spirit.

While the magnitude pales in comparison to terrorism, we entrepreneurs face daily challenges

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

that test our will and resolve; yet, we overcome, learn and grow as we continue our “journey of success.” The entrepreneurial spirit of our country continues to make us the greatest nation on earth

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

and provides us the freedom to pursue our passion for independence and make a difference in the lives of others.

According to Webster’s Dictionary the definition of entrepreneur is [a person who

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

rganizes and manages any enterprise, especially a business, usually with considerable initiative and risk.] Christopher Columbus set the foundation for entreprenuerism, at great risk, by pursuing h

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

s vision of a different world. Much later, the Pilgrims risked their lives to create a society free to worship and free of oppression.

Often times, we forget the so-called “giants” of industry als

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

Following aspects would a

o began as entrepreneurial ventures fueled by a vision to create a better world. Our history books portray the likes of Thomas Edison, Henry Ford, Andrew Carnegie, the Vanderbilt's, and many others

dd to the challenges in developing combination products:

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

With the combination of a cooling economy and the world-changing events of September 11th, this is an important time to pause, reflect and review the current status of your business. Although man

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

y uncertainties lie ahead, we must adjust our thinking and plan various scenarios to cope with and survive this new world we now live in.

One attitude adjustment many companies need to make is how

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

they view their customers (internal and external). When you demonstrate to your customers that you value their business in good times, they are more likely to stay with you in bad times. Everyone w

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

ns in customer-focused environment.

Depending upon the markets served, some organizations will have to slightly alter the way business is conducted, others may need to make radical changes. Either

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

Professional from academic institutions, pharmaceutical industries, health care indust

way, every ounce of creativity and innovative thinking we can muster is required. Huge egos and attitudes of self interest can not continue. Leadership is paramount to success. President George W.

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

Bush and New York Mayor Rudy Giuliani have demonstrated exceptional leadership in their respective positions.

Like many times before, I am uncertain about the immediate future but I have NO doubts

.

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

that the entrepreneurial spirit that exists in America will prevail. Entrepreneurs have many new challenges to face, yet if we open our heart, eyes, ears, mind; renew our passion and determination

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

Companies that provide selfless information through particip

that got us here; and make the necessary adjustments to attain the success we strive for…just like America, we will continue to live, work and thrive in “the land of the free and home of the brave.

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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