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Everything seems to revolve around money in today's society. How much you earn, what kind of portfolio do you have, and what is your bottom line permeate conversations, news stories, and TV and radio broad- casts.

It isn't only individuals who spend money or even cor- porations and stores. Our go

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

vernment spends money that is collected from working men/women and most is earmarked for certain programs, departments, or projects, not to mention the salaries paid to government officials from the White House to the people who do the work behind the scenes - the cooks, cleaning personnel and aux

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

Examples of combination products may in

iliary staff. While families budget and try to make ends meet, the largest spender of our money, namely the government, does not seem to care how much is used because there is a steady supply of new money coming in through taxes and other government demands. Take for example the war in Iraq. In

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

all honesty, how can we pour billions more into a war that seems to have no end, with leaders who cannot decide what is right or wrong, and a country that takes more than money, but the lives of our men/women as well. While supporting the troops that are there with whatever they need and earmarki

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

g funds to take care of the wounded once they come home, why is so much money being placed in a "program" that does not have the public's support and is a political baseball that is batted when publicity and votes matter. Just for a second, imagine that the literally billions of hard-eanred money

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

Combination pro

is used to make sure that our children can get the education they need to compete in a technological world, that seniors get their medications without opting to give up food or housing to get it, and the poor among us, such as the homeless or even the victims of Katrina have the funds needed to live

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

life with at least the basics. What about health-care? If the cost of medical attention keeps rising, that would be more than enough money to make sure that everyone can make themselves available to a doctor, hospital or facility without losing their homes and their pride.

The war in Iraq is to th

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

point that the elected officials talk the talk but stop when it comes to walk the walk. Would they honestly like to place their children or their loved ones in harm's way or would the bickering over bills and issues to end something that was brought about dishonestly and without remorse by those w

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

hose agenda dicated that this be done but they were not affected by the toll it would take. Yet the President, Vice President and senators travel and appear on talk shows and at luncheons stating their stand but saying very little about the nitty gritty everyday concerns of the citizens that put th

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

em in office or pay their high salaries and "perk" benefits. They seem to dress just fine and travel and dine at the best of places, but we don't ever really see them trying to cut costs and save money for the guy or gal whose house is being repossessed, or whose grandmother lives in poverty beca

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

se she needs an assortment of pills to try and live a normal life. There are no outcries or bemoans about the costs that working people cannot afford, such as gas prices or food costs. Don't you just love it when the spotlight is on your government official finishing up a sumptious banquet of food,

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

Following aspects would a

and wearing a suit that you couldn't afford or a hairstyle that the neighborhood hair place would certainly not be able to duplicate for you. You sit there with your warmed over beef stew and go through your pockets so that your child's lunch money is available in the morning, or your sitter gets

dd to the challenges in developing combination products:

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

paid because tomorrow is Friday. You warm up to the first figure on your pay stub (before taxes) and it feels good, but soon you realize that the Net Box won't cover the house payment in just one check.

Iraq was a chain of undercover deceptions to let certain individuals accomplish whatever it was t

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

hey wanted to, or felt they had to. Where would everyday Joe or Jane be if they changed important documents, or swore on facts and figures that they knew were incorrect. Also, just a thought - it took our hard-earned money to pay for the television time to tell us the lies and falsehoods that we l

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

stened to. That just causes the injury to bleed a bit more. Would we not be punished without question if we violated the Constitution or laws of the land even though our minds told us we are free and have the right to do so? If we commit a crime, could we make excuses and continue in our high-pay

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

ing job because the money is there and even though we made poor judgment we are still able to decide where everyone else's money goes and who gets what?

Next Friday when you realize how your paycheck cannot cover your expenses to provide the kind of life you want for yourself and those you love, thin

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

Professional from academic institutions, pharmaceutical industries, health care indust

k about those who don't worry, fret, and cut corners. It just may make you upset a bit - but upset enough to make sure that they are aware of your feelings and complaints. After all, you are paying the bill and the benefits are their's. I'm sure that if the tables were turned around, you would he

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

r loud and clear cries from the bleachers if you enjoyed life to the fullest on someone else's money and day to day workday.

There is nothing wrong is making yourself heard - the only trouble is while people decide if they want to call attention to the outright and bold faults of the elected, the b

.

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

ill for their homes, families and future still comes out of your check. So isn't it time you speak up and make yourself a voice that wants to make things right for everyone - from babies to teens on to parents, grand- parents and those who fall in between. Isn't it a shame that our infrastructure i

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

Companies that provide selfless information through particip

s decaying and diasters leave people out in the cold right on our shores, but embassies worth billions are built around the world to house a few chosen who don't even think about the hours you put in so that they can live the lives they are used to and their children don't do without. Just a thought

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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