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Pick up the morning or evening newspaper and there are stories about current events, some tragic, and some humorous. You sit down with the paper because it is so important to be current about your own country and the world. Things are moving at a rapid pace and in the blink of an eye today's news is gone

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

forever and a barrage of new news takes its place.

The problem with American newspapers is that they are not to be believed word for word. They are censored and cut and pasted so that the average American is told only what this country would like him/her to know but not a word extra. In fact, if too muc

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

Examples of combination products may in

information is printed, then the reporter or newspaper is labeled as Unamerican and even said to have wrappings of treason. In other words, if something happens, we are not either smart enough, have enough education, or we lack the moral fortitude to hear it, ingest it, and go on with life. Our governmen

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

t believes that they have to preread everything, take that old marking pen out and erase what should not be made public knowledge. Now let's look at the other side of the coin. Our illustrious leaders also like to take pen in hand and add some "good things" to news clips about the wonderful things that t

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

ey are accomplishing and doing. A bit of lace and truly some arsenic for the public mind because shaping what people think, know and perceive as truthful is the chosen job of the government. Only your elected officials know what you should know, should be told, and when, how, and whatever. Doesn't it ju

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

Combination pro

t go against your grain to know that as an adult, you are not capable to think on your own. You have to be led around by the nose and spoon fed world events, current events, and even how very close to sainthood your leaders are. Otherwise, Lord knows, you would never equate government officials with hea

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

ven. By far, if you live in a false world made to order by those in charge, you will believe anything and you will be made to say, feel, and do exactly as the robots they hope you become.

This may be harsh words to hear but everyone with a brain in their head and eyes and ears to hear must by now know tha

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

they have to translate the article they are reading and do some checking to find out what really is going down and who is on the up and up. There are very few news conferences these days that you can rely on even with pictures, charts, and little flag pins on their lapels.

If you travel to foreign nation

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

s around the globe you find out that the citizens of the world know more about what is really happening here then any American does, except for the officials. They are told what we are truly not equipped to handle, yet alone live with. PIctures of uranium stockpiles and missile launching equipment really

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

ooked real on the news shows, and some of our leaders used charts and graphs to point to certain areas so that every American would truly know what the truth was. Why they even used the proper facial expressions to make their point and when they needed to look grave, they really did and when they want to

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

lighten up the true tragedy of the number of men, women, and children killed in a war, they wave and smile and pat us symbolically on the head so that we go to sleep and dream of sugar plums and toys.

Sorry to say, Americans have more going on in their craniums then most of our administration put together.

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

Following aspects would a

In fact, we can and do handle the bad news better than the government because if we did not, then mayhem would rule and they would be booed unmercifully for all the world to see. Yet we have enough integrity, and maturity to simply nod and agree, but our hearts are telling us the truth. We only have to l

dd to the challenges in developing combination products:

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

ok at the tears of a young child standing by their daddy, or mommy knowing they are going away. They may not understand why, but then many of the grown-ups don't either. The white crosses that are multiplying in the grave yards are not only marking the places of rest of the brave but they are pounded in

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

to the furtile grounds of the minds of millions of Americans who know that this is all wrong, and would like to see changes made. They write to their Congressmen, they talk about it with their friends and neighbors and they watch the news hoping that the words "The War Is Over" is the headline of the day.

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

But this has not happened yet.

As card-carrying adults, we must make a difference. We must put our childish beliefs aside and tell it like it is. A child killed here tragically is just as devastating to us as a child shot down in Iraq. Their parents bleed in their souls and they weep tears just as any par

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

nt here. When they bury their dead offspring, the earth does not know any difference. They are not Iraqi or American, they are just children unnecessaily killed and spent so that adults playing adults can have their agendas and reach their goals. Goals of world domination and agendas of controlling the

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

Professional from academic institutions, pharmaceutical industries, health care indust

natural resources before any other nation gets to them will never work. Julius Caesar thought so, so did Hitler and Stalin. Why President Bush may say there is no "cold" war, there is nothing chillier then the behind the closed door happenings in our nation's hallowed halls. From the Justice Department t

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

the State Department, from the CIA to the FBI, and every other department, the plans are not for the common good of all and they are not made with the best intentions. Maybe a select few will profit or be spared the pain of conflict, war, and torture, but not really. The conflict is in our hearts, the wa

.

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

r is for our minds, and the torture is knowing that we have to do something and yet another day rises and the status quo remains.

America for whatever reason you feel the most passion, use your mind and your heart to make changes. The children of today and those of tomorrow need our taking a stand and those

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

Companies that provide selfless information through particip

we have lost need this so that they can rest in peace. We have a right to know the truth now more than ever before. You have outgrown the need to be censored. If those of us who can don't make a difference, then those after us won't have the opportunity. Just think about it. ©Arleen M. Kaptur June, 200

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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