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It seems that saying the Iraq war was already "lost" was just not quite enough for Senate Majority Leader Harry Reid (D-NV). Apparently he and Speaker of the House Nancy Pelosi (D-CA) sent a letter to President Bush sa

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

ying, "...the escalation has failed to produce the intended results." So final judgment has been passed, as far as Reid and Pelosi are concerned, even though the last of the so-called "surge" troops involved in the Pre

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

Examples of combination products may in

ident's security plan for Baghdad and al-Anbar Province have just arrived in Iraq's capital.

Breitbart.com quotes the two Democratic congressional leaders as saying that "The increase in US forces has had little impac

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

in curbing the violence or fostering political reconciliation." Maybe I'm a little bit on the slow side here, but I just don't understand how someone can definitively declare a strategy dead before it has even had a c

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

ance to be implemented in its entirety. What happened to waiting for General Petraeus's report on progress, or the lack thereof, due to the Congress in September?

If our elected leaders actually have a little patience

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

Combination pro

and wait for the full plan to be put into action, they may be surprised at the results. In an interview with USATODAY on June 13, Petraeus said he was seeing "astonishing signs of normalcy" in at least half, and perhap

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

as much as two-thirds of Baghdad.

According to the paper Petraeus said, "I'm talking about professional soccer leagues with real grass field stadiums, several amusement parks-big ones, markets that are very vibrant."

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

Soccer leagues? Amusement parks? Vibrant markets? How can that possibly be the case if Baghdad is the center of what has been described as a country engulfed in a chaotic civil war where sectarian executions in the st

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

eet are common occurrences and where people are afraid to leave their homes out of fear of being caught in the running battles between insurgents, militias and coalition forces? Is General Petraeus lying to us (a claim

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

that is probably not far from the Senate Majority Leader's lips)? More importantly, what basis would he have for doing so? No, the likelihood is that the general sees a glimmer of hope and is merely reporting what he i

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

sensing as the head guy on the ground in Baghdad.

Now, this is not to say that everything is rosy in Baghdad, or elsewhere in Iraq for that matter. But it is a sign of possible progress in a country desperately seeki

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

Following aspects would a

g an end to the ongoing bloodshed and violence. And while Petraeus conceded in the interview that many problems still exist, he also said that what he sees is a sign that the new strategy in Iraq is working.

What Gene

dd to the challenges in developing combination products:

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

al Petraeus is seeing in Baghdad should come as no surprise, even to the casual observer of the conflict. The American military can pacify virtually any city in the world, but only for a limited amount of time. The key

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

to success for the "surge" security plan is, and always has been, the Iraqis themselves.

Iraqi security forces must be able to hold on to the areas cleared by American soldiers, and they must be non-sectarian in their

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

administration of Iraqi law. They must put the nation of Iraq above their loyalties to sheikh, tribe, militia, or sectarian affiliation. And the Iraqi government must live up to its responsibilities as well. That mean

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

providing services to the Iraqi people in a fair and just manner, and not based on whether they are Sunni, Shi'a or Kurd. It means making the political concessions necessary to achieve national reconciliation, includi

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

Professional from academic institutions, pharmaceutical industries, health care indust

g the distribution of oil revenues, adjustments to the Iraqi Constitution, and revision of de-Baathification policies. It means getting control of the militia death squads that are perpetuating the cycle of violence. A

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

d it means treating all Iraqis as Iraqis, fairly and equitably.

It is a tall order, to be sure. We can buy some time for the government in Baghdad, but only Iraqis can do what it takes to move their country forward. T

.

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

e breathing room we are providing for political progress is being paid for with the sweat and blood of our sons and daughters. The patience of America's citizens is quickly running out, and Iraqis should be cognizant o

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

Companies that provide selfless information through particip

this fact. But as the final "surge" troops move into place this weekend, the least we can do as Americans is wait until they've had a chance to execute their mission before passing judgment on their success or failure

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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