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They say hell is for children, but if Hell is for children what is the UN for; child

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

ren? If the President of the United States is truly the devil, as Hugo Ch?vez of Ven

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

Examples of combination products may in

zuela said so eloquently in a speech to the open assembly at the United Nations then

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

what does that make the United Nations?

If the axis of evil are all members of the

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

nited Nations and the Devil shows up to make a speech to. And all the dictators of t

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

Combination pro

e world are there are acting like children, then I guess the United Nations is that

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

lace? Am I wrong?

Perhaps I am not as wise as you and perhaps I do not know all 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

at goes on and I am one of the na?ve masses, so I hope you can explain to me why we

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

revent little kids from acting out with bad behavior in the sandbox at school and co

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

done this behavior at the United Nations?

It is important to open dialogue between

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

orld leaders, indeed that makes sense, but can you honestly call anything that is go

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

Following aspects would a

ng on in the United Nations open dialogue. It resembles more of a chicken fight to

dd to the challenges in developing combination products:

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

e, but I am just a young na?ve person, so what do I know?

If the President of Iran

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

s busy making nuclear weapons to blow Israel off the map as he has promised and he i

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

s currently sponsoring international terrorists to the tune of $100 million per year

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

then is it he bringing Hell to his neighbors and to the free world? But shouldn’t th

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

Professional from academic institutions, pharmaceutical industries, health care indust

t sort of thing and those concepts stay in hell? Why let them out?

If the United Na

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

ions condones this behavior then anyone who goes to the United Nations seems to be g

.

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

ing to hell in a hand basket. How can we build Utopia and unite in a common cause wh

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

Companies that provide selfless information through particip

le the childish leadership in hell calls the shots? Please consider all 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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