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Dear Mr. Bush,

In a publicity photo taken of you on Sunday, December 18, 2005, you were seated at your desk in the Oval Office and during one

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

of your infamous "chatters" you said, "We pray for the strength and safety of our troops." That was how you spent that particular Sunday.

W

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

Examples of combination products may in

ould you like to know or do you even care how I spent MY Sunday today? Well, it was almost like YOUR Sunday back in December. I too sat in m

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

y office and I too sat at my desk and I also prayed for the strength and safety of our troops. Especially one soldier in particular......my s

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

n. But unlike you, I sat in my office by my phone hoping and praying that my son was NOT aboard the Black Hawk Army copter. You see Mr. Bush

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

Combination pro

, my son is over there in the middle of this dreadful war you helped to rage against Iraq. He is also a member of the US Army. It is also VE

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

RY possible he was aboard that copter because it in fact left HIS area before the crash.

So today has been HELL Mr. Bush. Everytime I hear a

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

car door, I go racing to the window fearing the worst and expecting to see uniformed personnel delivering the news that every parent and famil

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

y member of every soldier dreads. Of course you can't really sympathize with that can you? You don't have anyone in the Military. No, you'r

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

e fine upstanding children are too busy getting DUI's. Yet you expect children of the rest of us to put their lives on the line. How peculia

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

is that?

No, I don't imagine our Sundays were that much alike afterall.

I have a confession Mr. Bush. I was idiotic enough to vote for you

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

Following aspects would a

. Yes, I confess, its true. It wasn't because I thought you were great as a candidate. It was not because I agreed with your views on abort

dd to the challenges in developing combination products:

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

ion or the death penalty because I DO NOT! It was because you claimed you would seek justice against those who tried to destroy the US. Or h

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

ave you gotten so caught up in your war game that you have forgotten? It was because I believed you had the backbone to seek restitution for

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

ll the lives lost on 9-11 that I even bothered listening to your constant chatter. You have failed us greatly. There has been no justice for

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

9-11 and now we have lost even MORE people because of this insane war.

I have listened to you pray for the troops, entertain their children

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

Professional from academic institutions, pharmaceutical industries, health care indust

over Christmas at the White House, etc etc. But I have only ONE question for you. WHY aren't they home where they belong????? You wanted th

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

s war so badly, why aren't YOU over there putting YOUR life on the line????

There will be no sleep at my house until we know the names of tho

.

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

se on board. And even if my son is not among them, sleep will not come easy. We will do our usual thing and light candles and pray for those

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

Companies that provide selfless information through particip

lives needlessly lost and for those they left behind without choice. I can only hope, you will pray for them too.

Sincerely,

A Military Mo

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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With the advancement of cable networks capable of providing two-way communications, such as telephone services and high-speed Internet access, cable operators have expanded their reach well into the business community. In fact, estimates suggest that cable internet services are available to almost 75% of the business community.

Telephones are no longer in their initial days of invention. They have left the time of being simply a device of communication far behind. Now they are flashy and powerful. So, one must be careful that he is buying the one that is rich in functionality and chic in design.

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