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Russia and China are both big suppliers and trading partners with Iran and much of

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

what they trade is advanced weapons systems and military hardware. Things like

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

Examples of combination products may in

ocket launchers, long-range missiles, uranium stock for enrichment and guns. Iran

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

has a million-man army and is currently bordered with Iraq. We have seen military

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

hardware from Iran in the hands of the insurgency in Iraq.

Iran wishes to enrich

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

Combination pro

ranium and make nuclear weapons and their president has already promised to; Blow

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

Israel off the Map. Even worse Iran is sponsoring Hezbollah and other internationa

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

terrorist organizations to the tune of over $100 million per year and you can see

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

how this is escalating.

The first world nations of the Western World wish to plac

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

sanctions on Iran and yet Russia says no sanctions for Iran and therefore will co

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

tinue to sell them weapons to fight in a future war. If other nations stopped trad

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

Following aspects would a

ing with Iran and Russia continues to trade with them and Russia also continues to

dd to the challenges in developing combination products:

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

sell jet fighter planes to countries like Venezuela, whose president also met with

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

the Iranian leader then we have a real problem.

As North Korea is testing nuclear

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

weapons and wants to test a nuclear bomb today and then sell these things to Iran

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

nd sell them nuclear weapons, we are into dangerous territory. If Iran gives nucl

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

Professional from academic institutions, pharmaceutical industries, health care indust

ear weapons to international terrorist organizations that they already sponsor the

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

we can expect a nuclear bomb detonation in a major Western World city within the

.

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

ext two years, will it be your city? If we fail at the present time to do anythin

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

Companies that provide selfless information through particip

about this that will be the most likely future. 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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