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    We are a nation of many different cultures and our people have come from all the far corners of the world seeking freedom and living a life as best they can, without war and condemnation. This was the ideal of the Statue of Liberty and many of our ancestors worked hard and long hours to provide a home for their family and food on the table.

    While we are a nation of many nationalities, we are not the world's Creator or the police service for every culture that is out there. If aid is needed or assistance for humanitarian reasons, then yes, since we are all human beings, we have a need to help others - but not to place
    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
    military all over the world, to interfere and cause governments to be overthrown and create conditions for riots and upheavals.

    We are the youngest nation around and therefore we do not have all the answers to heal all the earth's wounds. In addition, we do not have the God-given right to impose our ideals, ways, and belief systems on everyone else. We can help but not alter. We can assist but not redo. Many of the oldest cultures in the world have been living for centuries when we weren't around and they did not fold up and walk away. Some cultures died out - but these were usually the ones that tried to take
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    over and rule over all others.

    Our mandate in this sphere we live in is to help and give our friendship - not decide what is right or wrong for everyone else. Each country has their needs, their ways, and they do have their pride of ancestry. Who are we, truly, to decide all the issues facing every nation, putting our soldiers and staff in hundreds of other countries, deciding who should or should not win elections, and if not going our way, to incite and overthrow? No one informed the world that God died and the universe is not looking for a replacement.

    We should honor the ways of others, but be there if they nee
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    d food, medical equipment, or some country has decided that their neighbor should be annihilated and the people (the common every day man or woman) would be in pain. We do not own or should we covet all the resources of the world. We do not have the expertise, even though our government truly believes they do, to change entire cultures into our image. They are not "us" and we need to have the respect to give them the right to live as they choose, without our interference and without giving money and indoctrination to the side we believe is right. The people of each of the countries we interfere with are not being g
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ven the chance to run their own lives, their land, or choose what they desire. Most assuredly, our country should never overstep its bounds and deprive the citizens of the world from their choices and their decisions.

    Just picture another country coming here (and no, they are not on every street corner and at every football game, as the media would have you believe), distributing leaflets from the air about overthrowing our government, surrounding the Great Lakes and the oceans with ships and warplanes (just military training) and then deciding to enter our country even though we never stepped foot on their ground
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    or threw one bomb at them. Not only did we enter Iraq, but we do not intend to leave. We were not there to win hearts - we wanted oil and we wanted to control the Middle East.

    Millions are being put into an embassy to house Americans in Iraq for God forever, and now we want missile bases wherever we feel the need - even though it puts other nations on alert and causes rifts and problems. We are the rulers of the universe and you either are with us or against us. Hopefully, Rome, Germany, and other great cultures can arise and warn the people what can happen when world rule is the mandate and our way or no way is th
    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
    mantra. The house of cards will fall and then the other nations will look away because they stood by us because of fear, not friendship. We intimidated and threatened violence so they called themselves allies, but in the end, fear does not produce friendships.

    Our infrastructure is crumbling, our families are torn to shreds, education is a by- product and there is more violence here then ever before. Guns are being carried as in the Old West, people shoot each other just because they are there, and crime has become uglier and bloodier than ever in our history. More men and women are crippled from the war and they
    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
    do not get the support or medical attention they deserve. Yet withdrawal is not an option because of pride voiced as failure. In reality, we don't want to lose so our young give their blood and stain the ground with their bravery.

    TV shows our young that cheating and lying are part of the game, and the commercials exploit the desire to buy more even though you don't need it. Women are shown in clothing that has no shame, but then everyone wonders why rape and other sexual crimes are at an all-time high. Men have lost respect for women as women and use their strength to belittle and harm. Children are subjected to
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    assault and deviates - from neighbors, to family, to even men in their 70's and 80's. Even the dead are not at peace as rowdy teens desecrate and mutiliate graves and crypts. There are rallies and demonstrations by "illegal aliens" and no mention is made of the illegal actions they have taken. They demand rights here in our country not in theirs because they know their government has washed their hands of helping their own people because the U.S. will take care of it. We educate their children, give them medical care, and jobs. This allows companies not to have to pay a living wage to its own citizens because che
    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
    ap labor is plentiful and cries of "No American wants the job" brings TV cameras and newspaper interviews. The country that should be handling these problems and making inroads for their own people do not use their resources because the U.S. has truly taken over. We feed, clothe, educate, and give retirement to their people while many Americans do without.

    Gentleness and manners are few and far between, and people will kill to get that last dollar on the table. If another has to starve, lose everything because of medical emergencies, and children as well as families are homeless, the bottom line is that the oil bi
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    lionaries are raking it in by unheard of profits. "Me first" is on everyone's lips and children are being told "to kick ass." Childhood sports are shouting matches for parents and many resort to punches and even shooting of the other side. Our children do not believe in Santa Claus or the Easter Bunny but bow down to horrid monsters representing avengers and death.Shooting and mayhem are the rites of massage, not building castles in the sand and dreaming during warm summer days. Childhood is losing out while miniature adults are pushed and pulled as parents compete against each other. A child the size of a minute h
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    s already seen more violence then many adults did in their growing years.

    Holidays get in the way of jobs and sporting events, and children are no longer latch- key but are simply alone - in their homes, in their neighborhood and even in their hearts. People are sued if they admonish a child who may have run into the street, or broke a window - parents intervene with lawyers and money is the solution. Bullies make their parents proud, while the elderly are neglected and relegated to nursing homes and facilties. School shootings are no longer a shock. They have become items of news.

    Our country needs our country to
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    care about its people, to spend money on those who need it within our own borders. The world will crumble and destroy us as well as the earth if we don't do our part for the environment. Animals are becoming extinct, urban sprawl has no limits, and noise, air, and water pollution is rampant. Drug companies resemble drug lords, dispensing pills to wake you, put you to sleep, let you get through your day, decide when you want to die, determine how your children will look, and so forth. There is a pill for absolutely everything but the clincher is that there is very little research and most of it is biased or hidden,
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    and the products are found to cause more medical problems and disasters. Our food is tainted with additives and chemicals and obesity is prevalent while video games replace exercise and outdoor play. We say there is no arms race, yet the budget allows for better nuclear weaponry and facilities. There is no dictatorship, yet Congress and the Senate do the bidding when the Ruler nods his head or pats them on their wallets. We should be building fences of friendship instead of hidden torture camps in other lands and more prisons. We dismiss the Geneva Convention and Kyoto but we will do anything for more oil and f
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    uel. We show the dead and mutilated bodies of the other side, but are adament that our dead not be disgraced. They have been in the worse way - a war that should never had happened, and one that was brought about by lies and falsehoods dressed up in suits and news conferences.

    The Catholic Church is going bankrupt and closing parishes because of sex crimes and lies, corruption and greed permeate our government and civil servants. Soldiers are placed in harm's way and shoot to kill no matter the cause because of strain and fear, but there is no coming home or an end to the war. Congress, the Senate and your electe
    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
    officials are sworn to uphold the wants of their people, yet they do as they are told and back off of the really important issues because of "politics" It just doesn't look good to condemn bad decisions and take a stand - instead go where the votes are and rake in the money while you can. The party name is all that matters because the power is the goal - not the people and true democracy.

    What has happened to a concept of a country where people were going to be happy, healthy, and lead lives that allowed everyone a share of the pie? It's out there some- where, probably in the safe of one of the oil or drug corporat
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ions so that they can just figure out a way to do away with it - but they can't. It is in our hearts and souls, and while we may be in a drug stupor or fed lies three times a day and now our minds are foggy and our decisions faulty, we will prevail. We are Americans and we won our rights - we are all in this together - we just forgot how to do it . The people of the other lands that inhabit earth have the same rights - to choose, decide, and live the way they want to - without our interference, judgment, and pressure. We pay for the government to fight the war on crime, drugs, and the terrorists - yet, it is in th
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    very walls of the hollowed halls of the White House.

    What is the answer - we let live so we can live. We help where we can but leave the big decisions to the nations to contend with, and to carry out. We fight only when life and limb of people are at stake - such as AIDS, and genocide - but we stay out of elections. We are not the brightest stars in the heavens, because there are others who share the space. When we clean up our own back yards, and make the repairs to ourselves and our land - then and only then are we ready to be true guardians of the earth. When we can undo the humiliation and pain caused by put
    .

    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
    ting down the American Indians, those who spoke against issues, and those who are in jail even though innocent, then we are ready and all grown-up. Until then our growing pains should take up our time and space. We will survive but we must let others survive. We will win but we must let others run the race and score as well. We are a great nation among many - we are equal to all human beings, we are not gods and goddesses, and then and only then will we be truly free. We must look at our history and learn. We must look at the world history and see the warning signs that led to failure. Each man, woman, and chil
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    in this land is precious and should be at the forefront of all we do - yet egoes, and agendas as well as power greed have eaten up decency and democracy. Look inside and the answers are all there - take the time to really open your eyes and really see what is happening. It is not too late - but the clock is ticking. We are making enemies instead of bonding friendships. We are using war and weaponry instead of diplomacy and hand shakes. We are the only ones to change course - we have done it before and we can do it again - for those before us and especially for those here and now.

    ©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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