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For the last several years, the world has been witness to the rapid shift of influence in a Middle East traditionally dominated by Sunni Muslims. The ascendance of the Shiites, who make up only 20% 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

all Muslims, is led by an increasingly aggressive Iran, and complete control of the Persian Gulf region is quickly becoming a reality.

Iran's strategy for replacing long-established Middle Eastern Sun

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

Examples of combination products may in

i dominance with a new Shiite leadership in the region consists of three parts: fomenting unrest in Iraq to solidify Shiite control, the rapid pursuit of a nuclear program that would enhance Iran's pow

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

r and position in the Middle East, and a complete Hezbollah takeover of Lebanon.

It is no secret that Iraq's Shiites are greatly influenced by Iran. As part of its larger strategy for dominance 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

Middle East, though, the Iranian government has taken advantage of the chaos inside its neighbor's borders to increase instability and to promote the killing of Sunni Arabs by Shiite death squads. Weap

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

Combination pro

ns, bombs and radical fighters are regularly smuggled across the border, and reports indicate that Iranian-sponsored Hezbollah fighters are providing technical and tactical expertise as the clerical re

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

ime in Iran seeks to solidify the power of a Shiite-led government that will ally itself with its former foe. With Shiites making up nearly 60% of the Iraqi population, the days of Sunni-minority rule

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

are over and Iran is in perfect position to spread its influence in the region while making Iraq's Sunni Arab neighbors increasingly uneasy.

While the United States continues to find itself bogged dow

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

in Iraq, the Iranian government continues its pursuit of nuclear technology with major help from Vladimir Putin's Russia. Iranian President Mahmoud Ahmadinejad summarily dismisses demands from an impo

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

ent United Nations because the Security Council is so fractured that military action or meaningful sanctions are unlikely to be agreed upon by the permanent five members. So, while Russia continues to

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

ubmit weaker drafts of a sanctions resolution in order to protect its financial stake in Iran's nuclear program, and while France and China continue to push for more time, the clerical regime in Tehran

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

Following aspects would a

keeps promising future talks (despite a U.N. deadline that passed months ago) as it continues its drive to become a member of the nuclear club. The acquisition of a nuclear capability by Iran would mak

dd to the challenges in developing combination products:

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

it the undisputed power in a violent and unstable region.

Finally, Iran has been aggressively pushing a complete Hezbollah takeover of long-time Syrian satellite Lebanon. Hezbollah already controls s

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

veral seats in the Lebanese parliament, and has thoroughly infiltrated the Lebanese Army. At Iran's urging, Hezbollah used its state-within-a-state in southern Lebanon to launch a new conflict with nei

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

ghboring Israel this past summer, a conflict that emboldened the terrorist group's Iranian benefactors and increased Hezbollah's popularity among the Lebanese populace. The recent assassination of Indu

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

try Minister Pierre Gemayel, who was a fierce opponent of Hezbollah and Iranian-allied Syria, pushed the Lebanese government dangerously close to a complete collapse. If that collapse happens, Lebanon

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould face new elections that would probably increase the power and control of Hezbollah, and by default, Iran.

With the continued promotion of a Shiite dominated Iraqi government, the defiant pursuit

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

f nuclear technology, and the consolidation of Shiite Hezbollah's power in Lebanon, Iran is becoming increasingly powerful and poised to lead a period of Shiite supremacy in a predominantly Sunni Middl

.

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

East. Sunni countries allied with, or at least tolerant of the United States, as well as Israel, are faced with the prospect of a nuclear-armed Iran with tremendous influence and control in both Iraq

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

Companies that provide selfless information through particip

nd Lebanon. The power play for Shiite dominance in the Middle East is quickly acting itself out, and Iran may soon get the recognition as a major regional and global player that it so desperately seeks

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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