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United States military has now stated that the death toll for Ir

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

aq has reached 2500 people which is about the average number of

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

Examples of combination products may in

people are killed on American highways during any three-day week

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

end.

It is important to put everything into perspective when di

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

scussing the number of US military deaths in Iraq and understand

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

Combination pro

that although we cannot know all possible futures that there is

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

a very good chance that our involvement in Iraq has prevented W

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

orld War Three. In other words had Saddam continued and the Iran

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

ians continued to develop weapons and this high pace we very eas

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

ily could have had WW III.

Preventing World War III and having

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

00’s of millions of people killed may well have been worth the s

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

Following aspects would a

acrifice of these 2500 brave soldiers and it is time that we und

dd to the challenges in developing combination products:

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

erstand that great goals and efforts amongst mankind does indeed

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

come with sacrifice. We should be honoring these 2500 soldiers

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

rather than using their deaths as political ammunition to attack

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

ourselves.

It is amazing how facts and figures get thrown arou

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd in our media and how some politicians use these numbers to pr

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

opel political careers. What is a shame is that we indeed listen

.

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

to these folks at all as they condemn the very reason that our

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

Companies that provide selfless information through particip

Nation today is so strong. I hope you will consider 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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